Case Series Drug Analysis Print
Name: Human Papillomavirus brand unspecified Drug Analysis Print
Report Run Date:
12-Mar-2015
Data Lock Date:
11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: 17.1
Reports of HPV where the brand name has not been reported.
Report Run Date: 12-Mar-2015, Page 1
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Blood disorders
Anaemia deficiencies
Anaemia vitamin B12 deficiency
1
0
Anaemias NEC
Anaemia
2
0
Lymphatic system disorders NEC
Lymphadenopathy
2
0
Blood disorders SOC TOTAL
5
0
Report Run Date: 12-Mar-2015, Page 2
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Cardiac disorders
Cardiac signs and symptoms NEC
Cyanosis
1
0
Palpitations
2
0
Cardiac disorders SOC TOTAL
3
0
Report Run Date: 12-Mar-2015, Page 3
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Ear disorders
Ear disorders NEC
Ear pain
3
0
Hearing losses
Deafness
2
0
Hyperacusia
Hyperacusis
1
0
Inner ear signs and symptoms
Vertigo
1
0
Ear disorders SOC TOTAL
7
0
Report Run Date: 12-Mar-2015, Page 4
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Endocrine disorders
Adrenal cortical hypofunctions
Adrenocortical insufficiency acute
1
0
Endocrine abnormalities of puberty
Delayed puberty
1
0
Endocrine disorders SOC TOTAL
2
0
Report Run Date: 12-Mar-2015, Page 5
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Eye disorders
Blindness (excl colour blindness)
Blindness
2
0
Blindness transient
1
0
Choroid and vitreous structural change, deposit and degeneration
Vitreous floaters
1
0
Iris and uveal tract infections, irritations and inflammations
Uveitis
1
0
Lid, lash and lacrimal infections, irritations and inflammations
Eyelid oedema
4
0
Ocular disorders NEC
Eye disorder
2
0
Eye pain
5
0
Eye swelling
2
0
Ocular discomfort
1
0
Ocular infections, inflammations and associated manifestations
Eye discharge
1
0
Eye inflammation
1
0
Eye pruritus
1
0
Ocular nerve and muscle disorders
Eye movement disorder
1
0
Ocular myasthenia
1
0
Ocular sensation disorders
Asthenopia
1
0
Photophobia
1
0
Optic disc abnormalities NEC
Optic disc disorder
1
0
Partial vision loss
Visual acuity reduced
2
0
Pupil disorders
Pupillary reflex impaired
1
0
Retinal, choroid and vitreous infections and inflammations
Retinal vasculitis
1
0
Visual disorders NEC
Photopsia
1
0
Vision blurred
14
0
Visual impairment
5
0
Eye disorders SOC TOTAL
51
0
Report Run Date: 12-Mar-2015, Page 6
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Gastrointestinal disorders
Diarrhoea (excl infective)
Diarrhoea
10
0
Dyspeptic signs and symptoms
Eructation
1
0
Flatulence, bloating and distension
Abdominal distension
1
0
Gastric ulcers and perforation
Gastritis erosive
1
0
Gastrointestinal and abdominal pains (excl oral and throat)
Abdominal pain
21
0
Abdominal pain lower
2
0
Abdominal pain upper
15
0
Gastrointestinal atonic and hypomotility disorders NEC
Constipation
1
0
Gastrointestinal hypomotility
1
0
Gastrooesophageal reflux disease
1
0
Gastrointestinal disorders NEC
Gastrointestinal disorder
1
0
Gastrointestinal signs and symptoms NEC
Abdominal discomfort
3
0
Aphagia
2
0
Dysphagia
3
0
Gastrointestinal spastic and hypermotility disorders
Irritable bowel syndrome
3
0
Gingival disorders NEC
Gingival disorder
1
0
Nausea and vomiting symptoms
Nausea
76
0
Vomiting
45
0
Non-site specific gastrointestinal haemorrhages
Haematemesis
1
0
Oral dryness and saliva altered
Dry mouth
1
0
Oral soft tissue pain and paraesthesia
Odynophagia
1
0
Paraesthesia oral
1
0
Oral soft tissue signs and symptoms
Hypoaesthesia oral
1
0
Oral soft tissue swelling and oedema
Lip swelling
3
0
Mouth swelling
1
0
Tongue signs and symptoms
Glossodynia
1
0
Swollen tongue
3
0
Gastrointestinal disorders SOC TOTAL
201
0
Report Run Date: 12-Mar-2015, Page 7
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
General disorders
Asthenic conditions
Asthenia
20
0
Chronic fatigue syndrome
7
0
Fatigue
59
0
Malaise
68
0
Febrile disorders
Pyrexia
66
0
Feelings and sensations NEC
Chills
5
0
Feeling abnormal
4
0
Feeling cold
4
0
Feeling hot
7
0
Feeling jittery
1
0
Feeling of body temperature change
1
0
Temperature intolerance
1
0
Thirst
1
0
Gait disturbances
Abasia
4
0
Gait disturbance
5
0
General signs and symptoms NEC
Condition aggravated
2
0
Exercise tolerance decreased
1
0
General physical health deterioration
1
0
Influenza like illness
17
0
Local reaction
2
0
Local swelling
2
0
Peripheral swelling
18
0
Swelling
4
0
Injection site reactions
Injection site bruising
1
0
Injection site coldness
3
0
Injection site discolouration
2
0
Injection site erythema
10
0
Injection site granuloma
1
0
Injection site haemorrhage
1
0
Injection site hypoaesthesia
3
0
Injection site injury
1
0
Injection site mass
5
0
Injection site movement impairment
1
0
Injection site pain
9
0
Injection site pruritus
3
0
Injection site rash
2
0
Injection site reaction
5
0
Injection site swelling
13
0
Injection site warmth
1
0
Mass conditions NEC
Mass
2
0
Pain and discomfort NEC
Chest discomfort
3
0
Chest pain
5
0
Discomfort
2
0
Facial pain
1
0
Pain
29
0
Report Run Date: 12-Mar-2015, Page 8
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
General disorders General disorders cont'd
Tenderness
2
0
General disorders SOC TOTAL
405
0
Report Run Date: 12-Mar-2015, Page 9
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Hepatic disorders
Cholestasis and jaundice
Jaundice
1
0
Hepatocellular damage and hepatitis NEC
Autoimmune hepatitis
1
0
Hepatic disorders SOC TOTAL
2
0
Report Run Date: 12-Mar-2015, Page 10
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Immune system disorders
Allergic conditions NEC
Allergy to animal
1
0
Hypersensitivity
6
0
Type IV hypersensitivity reaction
1
0
Allergies to foods, food additives, drugs and other chemicals
Drug hypersensitivity
1
0
Food allergy
1
0
Rubber sensitivity
1
0
Anaphylactic responses
Anaphylactic reaction
6
0
Autoimmune disorders NEC
Autoimmune disorder
1
0
Immune and associated conditions NEC
Immune system disorder
1
0
Immunisation reaction
1
0
Immune system disorders SOC TOTAL
20
0
Report Run Date: 12-Mar-2015, Page 11
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Infections
Abdominal and gastrointestinal infections
Appendicitis
1
0
Central nervous system and spinal infections
Encephalitis
2
0
Ear infections
Labyrinthitis
1
0
Epstein-Barr viral infections
Infectious mononucleosis
1
0
Eye and eyelid infections
Hordeolum
1
0
Herpes viral infections
Herpes zoster
2
0
Infections NEC
Infection
1
0
Infection susceptibility increased
1
0
Respiratory tract infection
1
0
Skin structures and soft tissue infections
Skin infection
1
0
Upper respiratory tract infections
Epiglottitis
1
0
Nasopharyngitis
1
0
Upper respiratory tract infection
1
0
Viral infections NEC
Gastroenteritis viral
1
0
Post viral fatigue syndrome
8
0
Viral infection
1
0
Infections SOC TOTAL
25
0
Report Run Date: 12-Mar-2015, Page 12
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Injuries
Maladministrations
Inappropriate schedule of drug administration
1
0
Overdoses
Intentional overdose
1
0
Peripheral nerve injuries
Axillary nerve injury
1
0
Skin injuries NEC
Contusion
1
0
Injuries SOC TOTAL
4
0
Report Run Date: 12-Mar-2015, Page 13
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Investigations
Endocrine analyses and imaging NEC
Hormone level abnormal
1
0
Heart rate and pulse investigations
Heart rate increased
2
0
Heart rate irregular
1
0
Pulse abnormal
1
0
Investigations NEC
Quality of life decreased
1
0
Physical examination procedures and organ system status
Body temperature decreased
1
0
Body temperature fluctuation
1
0
Body temperature increased
13
0
Weight decreased
4
0
Vascular tests NEC (incl blood pressure)
Blood pressure increased
2
0
Investigations SOC TOTAL
27
0
Report Run Date: 12-Mar-2015, Page 14
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Metabolic disorders
Appetite disorders
Decreased appetite
11
0
Calcium metabolism disorders
Tetany
1
0
Diabetes mellitus (incl subtypes)
Diabetes mellitus inadequate control
1
0
Fat soluble vitamin deficiencies and disorders
Vitamin D deficiency
1
0
Hyperglycaemic conditions NEC
Hyperglycaemia
1
0
Iron deficiencies
Iron deficiency
2
0
Water soluble vitamin deficiencies
Vitamin B12 deficiency
1
0
Vitamin C deficiency
1
0
Metabolic disorders SOC TOTAL
19
0
Report Run Date: 12-Mar-2015, Page 15
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Muscle & tissue disorders
Arthropathies NEC
Arthritis reactive
1
0
Joint related signs and symptoms
Arthralgia
15
0
Joint effusion
1
0
Joint stiffness
2
0
Muscle pains
Myalgia
12
0
Muscle related signs and symptoms NEC
Muscle spasms
3
0
Muscle tightness
1
0
Muscle twitching
2
0
Muscle tone abnormalities
Muscle rigidity
2
0
Muscle weakness conditions
Muscular weakness
9
0
Musculoskeletal and connective tissue pain and discomfort
Back pain
10
0
Limb discomfort
6
0
Musculoskeletal discomfort
1
0
Musculoskeletal pain
3
0
Neck pain
3
0
Pain in extremity
40
0
Musculoskeletal and connective tissue signs and symptoms NEC
Back disorder
1
0
Mastication disorder
1
0
Mobility decreased
3
0
Musculoskeletal stiffness
9
0
Spinal pain
1
0
Weight bearing difficulty
1
0
Soft tissue disorders NEC
Groin pain
1
0
Muscle & tissue disorders SOC TOTAL
128
0
Report Run Date: 12-Mar-2015, Page 16
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Neoplasms
Pharyngeal and laryngeal neoplasms benign
Laryngeal papilloma
1
0
Skin neoplasms benign
Skin papilloma
1
0
Neoplasms SOC TOTAL
2
0
Report Run Date: 12-Mar-2015, Page 17
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Nervous system disorders
Acute polyneuropathies
Guillain-Barre syndrome
1
0
Autonomic nervous system disorders
Autonomic nervous system imbalance
1
0
Central nervous system haemorrhages and cerebrovascular accidents
Basal ganglia stroke
1
0
Central nervous system vascular disorders NEC
Vasculitis cerebral
1
0
Choreiform movements
Chorea
1
0
Coordination and balance disturbances
Balance disorder
2
0
Cerebellar ataxia
1
0
Coordination abnormal
2
0
Dysstasia
1
0
Cortical dysfunction NEC
Aphasia
2
0
Demyelinating disorders NEC
Demyelination
1
0
Disturbances in consciousness NEC
Altered state of consciousness
1
0
Lethargy
16
0
Loss of consciousness
5
0
Somnolence
13
0
Syncope
48
0
Dyskinesias and movement disorders NEC
Dyskinesia
3
0
Hypokinesia
3
0
Encephalitis NEC
Encephalitis autoimmune
1
0
Encephalopathies NEC
Hashimoto's encephalopathy
1
0
Facial cranial nerve disorders
VIIth nerve paralysis
2
0
Generalised tonic-clonic seizures
Generalised tonic-clonic seizure
3
0
Headaches NEC
Headache
116
0
Memory loss (excl dementia)
Amnesia
2
0
Memory impairment
1
0
Mental impairment (excl dementia and memory loss)
Cognitive disorder
1
0
Disturbance in attention
4
0
Migraine headaches
Basilar migraine
1
0
Migraine
5
0
Myelitis (incl infective)
Myelitis transverse
1
0
Narcolepsy and hypersomnia
Cataplexy
1
0
Hypersomnia
3
0
Narcolepsy
2
0
Report Run Date: 12-Mar-2015, Page 18
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Nervous system disorders
Nervous system disorders cont'd
Nervous system disorders NEC
Nervous system disorder
1
0
Neurologic visual problems NEC
Visual field defect
2
0
Neurological signs and symptoms NEC
Clonus
1
0
Dizziness
90
0
Dizziness postural
6
0
Meningism
1
0
Presyncope
4
0
Unresponsive to stimuli
1
0
Neuromuscular junction dysfunction
Myasthenia gravis
1
0
Optic nerve disorders NEC
Optic neuritis
1
0
Paraesthesias and dysaesthesias
Hyperaesthesia
3
0
Hypoaesthesia
24
0
Paraesthesia
16
0
Paralysis and paresis (excl cranial nerve)
Hemiparesis
1
0
Peripheral neuropathies NEC
Lumbosacral plexus lesion
1
0
Neuritis
1
0
Seizures and seizure disorders NEC
Convulsion
14
0
Epilepsy
5
0
Partial seizures
1
0
Sensory abnormalities NEC
Complex regional pain syndrome
3
0
Dysgeusia
1
0
Neuralgia
1
0
Sensory disturbance
3
0
Sensory loss
7
0
Sleep disturbances NEC
Sudden onset of sleep
1
0
Speech and language abnormalities
Aphonia
3
0
Speech disorder
1
0
Tremor (excl congenital)
Tremor
11
0
Nervous system disorders SOC TOTAL
452
0
Report Run Date: 12-Mar-2015, Page 19
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Pregnancy conditions
Maternal complications of labour NEC
Labour complication
1
0
Pregnancy conditions SOC TOTAL
1
0
Report Run Date: 12-Mar-2015, Page 20
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Psychiatric disorders
Abnormal behaviour NEC
Abnormal behaviour
1
0
Anxiety symptoms
Agitation
1
0
Anxiety
5
0
Behaviour and socialisation disturbances
Aggression
1
0
Disinhibition
1
0
Paranoia
1
0
Personality change
1
0
Confusion and disorientation
Confusional state
2
0
Disorientation
1
0
Depressive disorders
Depression
4
0
Dissociative states
Dissociation
1
0
Disturbances in initiating and maintaining sleep
Insomnia
4
0
Emotional and mood disturbances NEC
Irritability
2
0
Mood altered
1
0
Fear symptoms and phobic disorders (incl social phobia)
Fear of death
1
0
Fluctuating mood symptoms
Mood swings
1
0
Increased physical activity levels
Restlessness
2
0
Mood alterations with depressive symptoms
Decreased interest
1
0
Depressed mood
3
0
Depressive symptom
1
0
Mood disorders NEC
Listless
2
0
Panic attacks and disorders
Panic attack
1
0
Perception disturbances
Hallucination
1
0
Hallucination, visual
1
0
Psychotic disorder NEC
Psychotic disorder
1
0
Sleep disorders NEC
Sleep disorder
1
0
Stereotypies and automatisms
Head banging
1
0
Suicidal and self-injurious behaviour
Suicidal ideation
1
0
Suicide attempt
1
0
Psychiatric disorders SOC TOTAL
45
0
Report Run Date: 12-Mar-2015, Page 21
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Renal & urinary disorders
Bladder and urethral symptoms
Urinary incontinence
1
0
Glomerulonephritis and nephrotic syndrome
Focal segmental glomerulosclerosis
1
0
Renal & urinary disorders SOC TOTAL
2
0
Report Run Date: 12-Mar-2015, Page 22
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Reproductive & breast disorders
Menstruation and uterine bleeding NEC
Dysmenorrhoea
1
0
Menstrual disorder
2
0
Menstruation irregular
4
0
Menstruation with decreased bleeding
Amenorrhoea
4
0
Menstruation delayed
3
0
Menstruation with increased bleeding
Menorrhagia
2
0
Ovarian and fallopian tube cysts and neoplasms
Ovarian cyst
1
0
Ovarian and fallopian tube disorders NEC
Ovarian failure
1
0
Vulvovaginal disorders NEC
Vaginal ulceration
1
0
Reproductive & breast disorders SOC TOTAL
19
0
Report Run Date: 12-Mar-2015, Page 23
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Respiratory disorders
Breathing abnormalities
Dyspnoea
17
0
Hyperventilation
3
0
Respiratory distress
1
0
Bronchospasm and obstruction
Asthma
1
0
Wheezing
2
0
Coughing and associated symptoms
Cough
6
0
Laryngeal spasm, oedema and obstruction
Laryngeal oedema
1
0
Stridor
1
0
Lower respiratory tract signs and symptoms
Pleuritic pain
1
0
Nasal congestion and inflammations
Nasal congestion
2
0
Pharyngeal disorders (excl infections and neoplasms)
Pharyngeal oedema
2
0
Respiratory tract disorders NEC
Respiratory disorder
1
0
Upper respiratory tract signs and symptoms
Choking sensation
1
0
Dysphonia
1
0
Oropharyngeal pain
16
0
Throat irritation
2
0
Throat tightness
3
0
Respiratory disorders SOC TOTAL
61
0
Report Run Date: 12-Mar-2015, Page 24
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Skin disorders
Acnes
Acne
1
0
Alopecias
Alopecia
3
0
Alopecia areata
3
0
Alopecia totalis
1
0
Angioedemas
Swelling face
3
0
Apocrine and eccrine gland disorders
Cold sweat
3
0
Hyperhidrosis
5
0
Miliaria
2
0
Bullous conditions
Blister
2
0
Erythema multiforme
2
0
Dermal and epidermal conditions NEC
Dry skin
3
0
Pain of skin
2
0
Skin burning sensation
1
0
Skin discolouration
13
0
Skin disorder
1
0
Skin lesion
1
0
Skin reaction
2
0
Skin warm
1
0
Dermatitis and eczema
Dermatitis allergic
4
0
Eczema
1
0
Erythemas
Erythema
15
0
Rash erythematous
5
0
Hypopigmentation disorders
Vitiligo
1
0
Photosensitivity and photodermatosis conditions
Photosensitivity reaction
4
0
Pruritus NEC
Pruritus
10
0
Pruritus generalised
1
0
Rash pruritic
3
0
Psoriatic conditions
Psoriasis
1
0
Purpura and related conditions
Henoch-Schonlein purpura
2
0
Petechiae
2
0
Purpura
2
0
Rashes, eruptions and exanthems NEC
Rash
30
0
Rash generalised
5
0
Rash macular
3
0
Urticarias
Urticaria
17
0
Urticaria pigmentosa
1
0
Skin disorders SOC TOTAL
156
0
Report Run Date: 12-Mar-2015, Page 25
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Social circumstances
Disability issues
Activities of daily living impaired
3
0
Bedridden
1
0
Social circumstances SOC TOTAL
4
0
Report Run Date: 12-Mar-2015, Page 26
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Surgical & medical procedures
Limb therapeutic procedures
Limb immobilisation
1
0
Surgical & medical procedures SOC TOTAL
1
0
Report Run Date: 12-Mar-2015, Page 27
Case Series Drug Analysis Print
Name: Human Papillomavirus Unbranded Drug Analysis Print
Report Run Date: 12-Mar-2015
Data Lock Date: 11-Mar-2015 19:00:07
Earliest Reaction Date: 10-Apr-2008
MedDRA Version: MedDRA 17.1
Reaction Name
Total Fatal
Vascular disorders
Lymphoedemas
Lymphoedema
1
0
Non-site specific embolism and thrombosis
Thrombosis
1
0
Non-site specific necrosis and vascular insufficiency NEC
Vasospasm
1
0
Peripheral embolism and thrombosis
Thrombophlebitis superficial
1
0
Peripheral vascular disorders NEC
Flushing
4
0
Hot flush
3
0
Peripheral vasoconstriction, necrosis and vascular insufficiency
Peripheral coldness
9
0
Raynaud's phenomenon
1
0
Site specific vascular disorders NEC
Pallor
14
0
Vascular disorders SOC TOTAL
35
0
TOTAL REACTIONS FOR DRUG
1677
0
TOTAL REPORTS
499
Report Run Date: 12-Mar-2015, Page 28