This is an HTML version of an attachment to the Freedom of Information request 'Summary Minutes for CHM meeting on 16th & 17th July 2015'.

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date:
26-Jun-2015
Data Lock Date:
24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version:
MedDRA 18.0
Gardasil:
Gardasil Drug Analysis Print
Report Run Date: 26-Jun-2015, Page 1

 
Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Blood disorders
   Anaemias NEC
      Anaemia
3
0
   Bleeding tendencies
      Increased tendency to bruise
1
0
   Coagulopathies
      Coagulopathy
1
0
   Haematological disorders
      Blood disorder
1
0
   Lymphatic system disorders NEC
      Lymph node pain
1
0
      Lymphadenopathy
9
0
Blood disorders SOC TOTAL
16
0
Report Run Date: 26-Jun-2015, Page 2

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Cardiac disorders
   Cardiac signs and symptoms NEC
      Cyanosis
6
0
      Palpitations
3
0
   Rate and rhythm disorders NEC
      Postural orthostatic tachycardia syndrome
4
0
      Tachycardia
5
0
   Supraventricular arrhythmias
      Sinus arrhythmia
1
0
Cardiac disorders SOC TOTAL
19
0
Report Run Date: 26-Jun-2015, Page 3

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Ear disorders
   Ear disorders NEC
      Ear pain
2
0
   Hearing losses
      Deafness
2
0
      Deafness transitory
1
0
      Hearing impaired
2
0
      Hypoacusis
1
0
   Inner ear signs and symptoms
      Tinnitus
2
0
      Vertigo
3
0
Ear disorders SOC TOTAL
13
0
Report Run Date: 26-Jun-2015, Page 4

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Endocrine disorders
   Thyroid hypofunction disorders
      Hypothyroidism
1
0
Endocrine disorders SOC TOTAL
1
0
Report Run Date: 26-Jun-2015, Page 5

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Eye disorders
   Blindness (excl colour blindness)
      Blindness
2
0
      Blindness transient
3
0
   Choroid and vitreous structural change, deposit and degeneration
      Vitreous floaters
2
0
   Eyelid movement disorders
      Eyelid ptosis
1
0
   Glaucomas (excl congenital)
      Glaucoma
1
0
   Iris and ciliary body structural change, deposit and degeneration
      Iris adhesions
1
0
   Iris and uveal tract infections, irritations and inflammations
      Iritis
1
0
   Lacrimation disorders
      Lacrimation increased
1
0
   Lid, lash and lacrimal infections, irritations and inflammations
      Eyelid oedema
4
0
   Ocular disorders NEC
      Eye pain
1
0
      Eye swelling
4
0
   Ocular infections, inflammations and associated manifestations
      Eye irritation
1
0
      Ocular hyperaemia
1
0
   Ocular nerve and muscle disorders
      Eye movement disorder
8
0
   Ocular sensation disorders
      Asthenopia
1
0
      Photophobia
4
0
   Partial vision loss
      Visual acuity reduced
1
0
   Pupil disorders
      Mydriasis
3
0
      Pupillary disorder
1
0
   Visual disorders NEC
      Diplopia
4
0
      Halo vision
1
0
      Photopsia
1
0
      Vision blurred
32
0
      Visual impairment
10
0
Eye disorders SOC TOTAL
89
0
Report Run Date: 26-Jun-2015, Page 6

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Gastrointestinal disorders
   Acute and chronic pancreatitis
      Pancreatitis
1
0
   Anal and rectal disorders NEC
      Anal fissure
1
0
   Colitis (excl infective)
      Colitis ulcerative
1
0
   Diarrhoea (excl infective)
      Diarrhoea
14
0
   Dyspeptic signs and symptoms
      Dyspepsia
2
0
   Flatulence, bloating and distension
      Abdominal distension
2
0
   Gastritis (excl infective)
      Gastritis
2
0
      Reflux gastritis
1
0
   Gastrointestinal and abdominal pains (excl oral and throat)
      Abdominal pain
26
0
      Abdominal pain lower
3
0
      Abdominal pain upper
28
0
      Abdominal tenderness
1
0
   Gastrointestinal atonic and hypomotility disorders NEC
      Constipation
1
0
      Gastrointestinal hypomotility
1
0
      Gastrooesophageal reflux disease
1
0
   Gastrointestinal disorders NEC
      Gastrointestinal disorder
2
0
   Gastrointestinal dyskinetic disorders
      Gastrointestinal motility disorder
1
0
   Gastrointestinal inflammatory disorders NEC
      Gastrointestinal inflammation
1
0
   Gastrointestinal mucosal dystrophies and secretion disorders
      Oesophageal mucosal hyperplasia
1
0
   Gastrointestinal signs and symptoms NEC
      Abdominal discomfort
9
0
      Dysphagia
2
0
   Gastrointestinal spastic and hypermotility disorders
      Irritable bowel syndrome
2
0
   Haemorrhoids and gastrointestinal varices (excl oesophageal)
      Haemorrhoids
1
0
   Inguinal hernias
      Inguinal hernia
1
0
   Nausea and vomiting symptoms
      Nausea
269
0
      Retching
3
0
      Vomiting
107
0
      Vomiting projectile
1
0
   Non-site specific gastrointestinal haemorrhages
      Haematemesis
2
0
   Oral soft tissue pain and paraesthesia
      Paraesthesia oral
7
0
   Oral soft tissue signs and symptoms
      Oral mucosal eruption
1
0
   Oral soft tissue swelling and oedema
Report Run Date: 26-Jun-2015, Page 7

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Gastrointestinal disorders
Gastrointestinal disorders cont'd
      Lip swelling
4
0
   Stomatitis and ulceration
      Mouth ulceration
1
0
   Tongue signs and symptoms
      Swollen tongue
2
0
Gastrointestinal disorders SOC TOTAL
502
0
Report Run Date: 26-Jun-2015, Page 8

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
General disorders
   Asthenic conditions
      Asthenia
30
0
      Chronic fatigue syndrome
1
0
      Fatigue
87
0
      Malaise
137
0
   Body temperature altered
      Temperature regulation disorder
1
0
   Febrile disorders
      Pyrexia
73
0
   Feelings and sensations NEC
      Chills
12
0
      Feeling abnormal
12
0
      Feeling cold
9
0
      Feeling drunk
1
0
      Feeling hot
38
0
      Feeling jittery
1
0
      Feeling of body temperature change
4
0
   Gait disturbances
      Abasia
3
0
      Gait disturbance
7
0
   General signs and symptoms NEC
      Condition aggravated
2
0
      Crying
5
0
      Foaming at mouth
1
0
      Influenza like illness
7
0
      Local reaction
5
0
      Local swelling
6
0
      Peripheral swelling
57
0
      Swelling
4
0
   Inflammations
      Inflammation
5
0
   Injection site reactions
      Injected limb mobility decreased
2
0
      Injection site bruising
3
0
      Injection site erythema
10
0
      Injection site haemorrhage
1
0
      Injection site hypoaesthesia
4
0
      Injection site induration
2
0
      Injection site mass
10
0
      Injection site movement impairment
1
0
      Injection site nerve damage
1
0
      Injection site oedema
1
0
      Injection site pain
23
0
      Injection site pruritus
6
0
      Injection site rash
1
0
      Injection site reaction
1
0
      Injection site swelling
20
0
      Injection site warmth
2
0
   Mass conditions NEC
      Mass
1
0
   Oedema NEC
      Face oedema
1
0
      Localised oedema
1
0
Report Run Date: 26-Jun-2015, Page 9

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
General disorders
General disorders cont'd
      Oedema peripheral
4
0
   Pain and discomfort NEC
      Chest discomfort
9
0
      Chest pain
8
0
      Discomfort
8
0
      Pain
28
0
      Tenderness
3
0
   Product quality issues NEC
      Product substitution issue
1
0
   Therapeutic and nontherapeutic responses
      Drug ineffective
1
0
      Immediate post-injection reaction
1
0
   Trophic disorders
      Atrophy
1
0
General disorders SOC TOTAL
663
0
Report Run Date: 26-Jun-2015, Page 10

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Hepatic disorders
   Hepatic and hepatobiliary disorders NEC
      Liver disorder
1
0
Hepatic disorders SOC TOTAL
1
0
Report Run Date: 26-Jun-2015, Page 11

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Immune system disorders
   Allergic conditions NEC
      Allergic oedema
1
0
      Hypersensitivity
12
0
   Allergies to foods, food additives, drugs and other chemicals
      Rubber sensitivity
1
0
   Anaphylactic responses
      Anaphylactic reaction
7
0
      Anaphylactic shock
1
0
   Autoimmune disorders NEC
      Autoimmune disorder
3
0
   Immune and associated conditions NEC
      Immune system disorder
3
0
Immune system disorders SOC TOTAL
28
0
Report Run Date: 26-Jun-2015, Page 12

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Infections
   Abdominal and gastrointestinal infections
      Gastrointestinal infection
1
0
   Bacterial infections NEC
      Cellulitis
1
0
   Candida infections
      Candida infection
1
0
      Vulvovaginal candidiasis
1
0
   Central nervous system and spinal infections
      Encephalitis
1
0
   Dental and oral soft tissue infections
      Gingivitis
1
0
   Ear infections
      Otitis media
1
0
   Female reproductive tract infections
      Amniotic cavity infection
1
0
      Pelvic inflammatory disease
1
0
   Herpes viral infections
      Herpes zoster
3
0
      Oral herpes
1
0
   Infections NEC
      Infection
1
0
      Injection site infection
1
0
   Influenza viral infections
      Influenza
1
0
   Lower respiratory tract and lung infections
      Lower respiratory tract infection
1
0
   Papilloma viral infections
      Papilloma viral infection
1
0
   Sepsis, bacteraemia, viraemia and fungaemia NEC
      Septic rash
1
0
   Streptococcal infections
      Beta haemolytic streptococcal infection
1
0
   Upper respiratory tract infections
      Nasopharyngitis
6
0
      Pharyngitis
1
0
      Sinusitis
1
0
   Urinary tract infections
      Urinary tract infection
1
0
   Viral infections NEC
      Post viral fatigue syndrome
2
0
      Viral infection
1
0
Infections SOC TOTAL
32
0
Report Run Date: 26-Jun-2015, Page 13

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Injuries
   Exposures associated with pregnancy, delivery and lactation
      Exposure during pregnancy
2
0
      Foetal exposure during pregnancy
2
0
   Non-site specific injuries NEC
      Fall
3
0
   Poisoning and toxicity
      Poisoning
1
0
   Site specific injuries NEC
      Head injury
1
0
   Skin injuries NEC
      Contusion
4
0
   Thermal burns
      Thermal burn
1
0
   Vaccination related complications
      Vaccination complication
1
0
Injuries SOC TOTAL
15
0
Report Run Date: 26-Jun-2015, Page 14

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Investigations
   Blood gas and acid base analyses
      Oxygen saturation decreased
1
0
   Carbohydrate tolerance analyses (incl diabetes)
      Blood glucose decreased
1
0
   Cardiac auscultatory investigations
      Cardiac murmur
1
0
   ECG investigations
      Electrocardiogram QT prolonged
1
0
      Electrocardiogram T wave inversion
1
0
   Heart rate and pulse investigations
      Heart rate decreased
4
0
      Heart rate increased
5
0
      Pulse abnormal
1
0
      Pulse pressure decreased
1
0
   Mineral and electrolyte analyses
      Blood iron decreased
2
0
   Ophthalmic function diagnostic procedures
      Corneal reflex decreased
1
0
   Physical examination procedures and organ system status
      Body temperature fluctuation
1
0
      Body temperature increased
10
0
      Respiratory rate increased
1
0
      Weight decreased
2
0
      Weight increased
1
0
   Platelet analyses
      Platelet count decreased
1
0
   Protein analyses NEC
      Blood albumin abnormal
1
0
      Protein total abnormal
1
0
   Reproductive organ and breast histopathology procedures
      Smear cervix abnormal
1
0
   Vascular tests NEC (incl blood pressure)
      Blood pressure decreased
2
0
      Blood pressure immeasurable
1
0
      Blood pressure increased
1
0
   Vitamin analyses
      Vitamin B12 increased
1
0
Investigations SOC TOTAL
43
0
Report Run Date: 26-Jun-2015, Page 15

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Metabolic disorders
   Appetite disorders
      Appetite disorder
1
0
      Decreased appetite
13
0
   Calcium metabolism disorders
      Tetany
1
0
   Diabetes mellitus (incl subtypes)
      Type 1 diabetes mellitus
3
0
   Diabetic complications NEC
      Diabetic ketoacidosis
1
0
   Fat soluble vitamin deficiencies and disorders
      Vitamin D deficiency
1
0
   General nutritional disorders NEC
      Feeding disorder
1
0
      Weight gain poor
1
0
   Metabolic disorders NEC
      Metabolic disorder
1
0
   Sugar intolerance (excl glucose intolerance)
      Lactose intolerance
1
0
   Total fluid volume decreased
      Dehydration
1
0
   Water soluble vitamin deficiencies
      Vitamin B12 deficiency
1
0
Metabolic disorders SOC TOTAL
26
0
Report Run Date: 26-Jun-2015, Page 16

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Muscle & tissue disorders
   Arthropathies NEC
      Arthritis reactive
2
0
      Arthropathy
1
0
   Bone related signs and symptoms
      Pain in jaw
2
0
   Extremity deformities
      Foot deformity
1
0
   Joint related signs and symptoms
      Arthralgia
33
0
      Joint stiffness
2
0
      Joint swelling
4
0
   Muscle pains
      Myalgia
12
0
   Muscle related signs and symptoms NEC
      Muscle fatigue
1
0
      Muscle spasms
6
0
      Muscle tightness
2
0
      Muscle twitching
6
0
   Muscle tone abnormalities
      Muscle rigidity
8
0
   Muscle weakness conditions
      Muscular weakness
13
0
   Musculoskeletal and connective tissue pain and discomfort
      Back pain
6
0
      Limb discomfort
9
0
      Musculoskeletal discomfort
1
0
      Musculoskeletal pain
5
0
      Neck pain
7
0
      Pain in extremity
78
0
   Musculoskeletal and connective tissue signs and symptoms NEC
      Back disorder
1
0
      Mobility decreased
3
0
      Musculoskeletal stiffness
15
0
      Posture abnormal
1
0
      Weight bearing difficulty
2
0
   Rheumatoid arthropathies
      Juvenile idiopathic arthritis
1
0
   Synovial disorders
      Synovitis
1
0
Muscle & tissue disorders SOC TOTAL
223
0
Report Run Date: 26-Jun-2015, Page 17

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Neoplasms
   Bone neoplasms malignant (excl sarcomas)
      Bone cancer
1
0
   Islet cell neoplasms and APUDoma NEC
      Pancreatic neuroendocrine tumour metastatic
1
0
   Leukaemias acute lymphocytic
      T-cell type acute leukaemia
1
1
   Metastases to specified sites
      Metastases to liver
1
0
   Skin neoplasms benign
      Anogenital warts
1
0
      Skin papilloma
1
0
   Uterine neoplasms benign
      Uterine leiomyoma
1
0
Neoplasms SOC TOTAL
7
1
Report Run Date: 26-Jun-2015, Page 18

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Nervous system disorders
   Abnormal reflexes
      Areflexia
2
0
   Absence seizures
      Petit mal epilepsy
1
0
   Autonomic nervous system disorders
      Autonomic nervous system imbalance
1
0
   Central nervous system haemorrhages and cerebrovascular accidents
      Cerebral thrombosis
1
0
   Coordination and balance disturbances
      Ataxia
1
0
      Balance disorder
2
0
      Coordination abnormal
1
0
      Dysstasia
4
0
   Cortical dysfunction NEC
      Dyslexia
1
0
      Dyspraxia
1
0
   Disturbances in consciousness NEC
      Altered state of consciousness
1
0
      Consciousness fluctuating
1
0
      Depressed level of consciousness
2
0
      Lethargy
38
0
      Loss of consciousness
7
0
      Somnolence
21
0
      Syncope
181
0
   Dyskinesias and movement disorders NEC
      Dyskinesia
17
0
      Hypokinesia
2
0
      Movement disorder
4
0
   Facial cranial nerve disorders
      VIIth nerve paralysis
2
0
   Generalised tonic-clonic seizures
      Generalised tonic-clonic seizure
3
0
   Headaches NEC
      Cluster headache
2
0
      Headache
257
0
      Sinus headache
1
0
      Tension headache
1
0
   Memory loss (excl dementia)
      Amnesia
2
0
      Memory impairment
3
0
   Mental impairment (excl dementia and memory loss)
      Disturbance in attention
6
0
      Mental impairment
1
0
   Migraine headaches
      Migraine
10
0
   Mononeuropathies
      Peroneal nerve palsy
1
0
   Muscle tone abnormal
      Hypotonia
5
0
   Narcolepsy and hypersomnia
      Hypersomnia
4
0
   Nervous system disorders NEC
      Motor dysfunction
1
0
Report Run Date: 26-Jun-2015, Page 19

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Nervous system disorders
Nervous system disorders cont'd
      Nervous system disorder
1
0
   Neurological signs and symptoms NEC
      Dizziness
471
0
      Dizziness postural
1
0
      Hyporesponsive to stimuli
1
0
      Myoclonus
1
0
      Presyncope
9
0
      Slow response to stimuli
2
0
      Unresponsive to stimuli
11
0
   Paraesthesias and dysaesthesias
      Burning sensation
2
0
      Hypoaesthesia
35
0
      Paraesthesia
48
0
   Paralysis and paresis (excl cranial nerve)
      Hemiparesis
1
0
      Monoplegia
2
0
   Peripheral neuropathies NEC
      Peripheral sensory neuropathy
1
0
   Seizures and seizure disorders NEC
      Epilepsy
3
0
      Seizure
18
0
      Seizure anoxic
1
0
      Seizure like phenomena
2
0
      Tonic clonic movements
2
0
   Sensory abnormalities NEC
      Complex regional pain syndrome
2
0
      Neuralgia
1
0
      Sensory disturbance
4
0
      Sensory loss
3
0
   Speech and language abnormalities
      Dysarthria
2
0
      Slow speech
1
0
      Speech disorder
1
0
   Spinal cord and nerve root disorders NEC
      Spinal cord oedema
1
0
   Tremor (excl congenital)
      Tremor
36
0
Nervous system disorders SOC TOTAL
1251
0
Report Run Date: 26-Jun-2015, Page 20

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Pregnancy conditions
   Abortions spontaneous
      Abortion spontaneous
1
0
      Abortion threatened
1
0
   Gestational age and weight conditions
      Premature baby
1
1
   Hypertension associated disorders of pregnancy
      Pre-eclampsia
1
0
   Labour onset and length abnormalities
      Premature labour
1
0
   Maternal complications of pregnancy NEC
      Cervical incompetence
1
0
Pregnancy conditions SOC TOTAL
6
1
Report Run Date: 26-Jun-2015, Page 21

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Psychiatric disorders
   Abnormal behaviour NEC
      Abnormal behaviour
5
0
   Affect alterations NEC
      Inappropriate affect
1
0
   Anxiety symptoms
      Agitation
2
0
      Anxiety
6
0
   Behaviour and socialisation disturbances
      Aggression
1
0
      Disinhibition
1
0
      Paranoia
2
0
      Personality change
1
0
   Bipolar disorders
      Bipolar disorder
1
0
   Confusion and disorientation
      Confusional state
7
0
      Disorientation
6
0
   Deliria
      Delirium
1
0
   Delusional symptoms
      Delusion
1
0
   Depressive disorders
      Depression
1
0
   Disturbances in initiating and maintaining sleep
      Insomnia
1
0
   Emotional and mood disturbances NEC
      Emotional distress
3
0
      Mood altered
1
0
   Mood alterations with depressive symptoms
      Tearfulness
5
0
   Mood disorders NEC
      Apathy
1
0
      Listless
1
0
   Obsessive-compulsive disorders and symptoms
      Obsessive-compulsive disorder
1
0
   Panic attacks and disorders
      Panic attack
3
0
      Panic reaction
2
0
   Parasomnias
      Sleep terror
1
0
   Perception disturbances
      Hallucination
2
0
      Hallucination, auditory
2
0
   Sleep disorders NEC
      Sleep disorder
1
0
   Somatoform disorders
      Somatisation disorder
1
0
   Speech articulation and rhythm disturbances
      Screaming
1
0
   Suicidal and self-injurious behaviour
      Suicidal ideation
1
0
   Thinking disturbances
      Thought blocking
1
0
Report Run Date: 26-Jun-2015, Page 22

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Psychiatric disordersPsychiatric disorders cont'd
Psychiatric disorders SOC TOTAL
64
0
Report Run Date: 26-Jun-2015, Page 23

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Renal & urinary disorders
   Bladder and urethral symptoms
      Urinary incontinence
4
0
   Bladder infections and inflammations
      Cystitis noninfective
1
0
   Genitourinary tract infections and inflammations NEC
      Urinary tract inflammation
1
0
   Glomerulonephritis and nephrotic syndrome
      Nephrotic syndrome
1
0
   Renal disorders NEC
      Renal disorder
1
0
   Urinary abnormalities
      Proteinuria
1
0
Renal & urinary disorders SOC TOTAL
9
0
Report Run Date: 26-Jun-2015, Page 24

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Reproductive & breast disorders
   Cervix disorders NEC
      Cervical dysplasia
1
0
   Menstruation and uterine bleeding NEC
      Dysmenorrhoea
1
0
      Menstruation irregular
4
0
   Menstruation with decreased bleeding
      Amenorrhoea
2
0
      Oligomenorrhoea
1
0
   Menstruation with increased bleeding
      Menorrhagia
8
0
   Ovarian and fallopian tube cysts and neoplasms
      Polycystic ovaries
1
0
   Ovarian and fallopian tube disorders NEC
      Ovarian disorder
1
0
   Reproductive tract signs and symptoms NEC
      Pelvic pain
1
0
   Vulvovaginal disorders NEC
      Vaginal haemorrhage
1
0
Reproductive & breast disorders SOC TOTAL
21
0
Report Run Date: 26-Jun-2015, Page 25

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Respiratory disorders
   Breathing abnormalities
      Dyspnoea
25
0
      Hyperventilation
10
0
      Hypopnoea
4
0
      Tachypnoea
2
0
   Bronchospasm and obstruction
      Asthma
4
0
      Bronchospasm
2
0
      Wheezing
2
0
   Coughing and associated symptoms
      Cough
6
0
   Nasal congestion and inflammations
      Nasal congestion
1
0
   Nasal disorders NEC
      Epistaxis
3
0
   Pharyngeal disorders (excl infections and neoplasms)
      Pharyngeal erythema
1
0
      Pharyngeal oedema
1
0
   Respiratory tract disorders NEC
      Respiratory tract inflammation
1
0
   Upper respiratory tract signs and symptoms
      Choking sensation
1
0
      Dry throat
1
0
      Dysphonia
1
0
      Oropharyngeal pain
9
0
      Throat irritation
2
0
      Throat tightness
3
0
Respiratory disorders SOC TOTAL
79
0
Report Run Date: 26-Jun-2015, Page 26

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Skin disorders
   Acnes
      Acne
2
0
   Alopecias
      Alopecia
10
0
      Diffuse alopecia
1
0
   Angioedemas
      Angioedema
2
0
      Swelling face
10
0
   Apocrine and eccrine gland disorders
      Cold sweat
27
0
      Hyperhidrosis
17
0
      Miliaria
1
0
   Bullous conditions
      Blister
1
0
      Erythema multiforme
1
0
   Dermal and epidermal conditions NEC
      Dry skin
3
0
      Pain of skin
2
0
      Papule
2
0
      Skin discolouration
20
0
      Skin reaction
3
0
      Skin tightness
2
0
      Skin warm
11
0
   Dermatitis and eczema
      Dermatitis allergic
2
0
      Dermatitis contact
1
0
      Eczema
5
0
      Skin irritation
2
0
   Erythemas
      Erythema
32
0
      Generalised erythema
1
0
      Palmar erythema
1
0
      Rash erythematous
12
0
   Exfoliative conditions
      Skin exfoliation
1
0
   Nail and nail bed conditions (excl infections and infestations)
      Nail discolouration
1
0
   Panniculitides
      Erythema nodosum
1
0
   Pruritus NEC
      Pruritus
30
0
      Pruritus generalised
3
0
      Rash pruritic
9
0
   Purpura and related conditions
      Petechiae
1
0
      Purpura
1
0
   Rashes, eruptions and exanthems NEC
      Rash
56
0
      Rash generalised
11
0
      Rash macular
10
0
      Rash maculo-papular
1
0
      Rash papular
1
0
   Skin and subcutaneous conditions NEC
Report Run Date: 26-Jun-2015, Page 27

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Skin disorders
Skin disorders cont'd
      Skin mass
1
0
      Umbilical discharge
1
0
   Skin hyperplasias and hypertrophies
      Skin hypertrophy
1
0
   Urticarias
      Urticaria
48
0
Skin disorders SOC TOTAL
348
0
Report Run Date: 26-Jun-2015, Page 28

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Social circumstances
   Disability issues
      Activities of daily living impaired
4
0
      Physical disability
1
0
   Educational issues
      Educational problem
1
0
Social circumstances SOC TOTAL
6
0
Report Run Date: 26-Jun-2015, Page 29

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Surgical & medical procedures
   Hernia repairs
      Inguinal hernia repair
1
0
   Obstetric therapeutic procedures
      Ventouse extraction
1
0
Surgical & medical procedures SOC TOTAL
2
0
Report Run Date: 26-Jun-2015, Page 30

Case Series Drug Analysis Print
Name: Gardasil
Report Run Date: 26-Jun-2015
Data Lock Date: 24-Jun-2015 19:00:15
Earliest Reaction Date: 29-Nov-2006
MedDRA Version: MedDRA 18.0
Reaction Name
Total
Fatal
Vascular disorders
   Non-site specific embolism and thrombosis
      Thrombosis
1
0
   Peripheral vascular disorders NEC
      Flushing
14
0
      Hot flush
1
0
   Peripheral vasoconstriction, necrosis and vascular insufficiency
      Peripheral coldness
15
0
   Site specific vascular disorders NEC
      Pallor
76
0
   Vascular hypertensive disorders NEC
      Hypertension
1
0
   Vascular hypotensive disorders
      Hypotension
6
0
      Orthostatic hypotension
1
0
Vascular disorders SOC TOTAL
115
0
TOTAL REACTIONS FOR DRUG
3579
2
TOTAL REPORTS
1483
TOTAL FATAL OUTCOME REPORTS
2
Report Run Date: 26-Jun-2015, Page 31