This is an HTML version of an attachment to the Freedom of Information request 'HPV Vaccine Safety'.

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