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: Cervarix Product Analysis Print
Report Run Date:
01-Jul-2015
Data Lock Date:
30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version:
MedDRA 18.0
Cervarix PAP:               All Cervarix cases after 31/07/2012
Report Run Date: 01-Jul-2015, Page 1

 
Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Blood disorders
   Haematological disorders
      Mast cell activation syndrome
1
0
      Mastocytosis
1
0
   Lymphatic system disorders NEC
      Lymphadenopathy
3
0
   Spleen disorders
      Splenomegaly
1
0
   Thrombocytopenias
      Thrombocytopenia
1
0
Blood disorders SOC TOTAL
7
0
Report Run Date: 01-Jul-2015, Page 2

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Cardiac disorders
   Cardiac conduction disorders
      Atrioventricular block
1
0
   Cardiac signs and symptoms NEC
      Cyanosis
1
0
      Palpitations
3
0
   Pericardial disorders NEC
      Pericardial effusion
1
0
   Rate and rhythm disorders NEC
      Postural orthostatic tachycardia syndrome
3
0
Cardiac disorders SOC TOTAL
9
0
Report Run Date: 01-Jul-2015, Page 3

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Congenital disorders
   Non-site specific bone disorders congenital
      Osteopetrosis
1
0
   Tongue disorders congenital
      Ankyloglossia congenital
1
0
Congenital disorders SOC TOTAL
2
0
Report Run Date: 01-Jul-2015, Page 4

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Ear disorders
   Hearing losses
      Deafness
1
0
   Hyperacusia
      Hyperacusis
1
0
   Inner ear signs and symptoms
      Motion sickness
1
0
      Vertigo
2
0
Ear disorders SOC TOTAL
5
0
Report Run Date: 01-Jul-2015, Page 5

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Endocrine disorders
   Posterior pituitary disorders
      Diabetes insipidus
1
0
   Thyroid hypofunction disorders
      Hypothyroidism
1
0
Endocrine disorders SOC TOTAL
2
0
Report Run Date: 01-Jul-2015, Page 6

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Eye disorders
   Blindness (excl colour blindness)
      Blindness transient
1
0
   Ocular disorders NEC
      Eye disorder
1
0
   Ocular infections, inflammations and associated manifestations
      Eye irritation
1
0
   Ocular sensation disorders
      Photophobia
3
0
   Partial vision loss
      Visual acuity reduced
1
0
   Pupil disorders
      Pupil fixed
1
0
   Refractive and accommodative disorders
      Altered visual depth perception
1
0
   Visual disorders NEC
      Vision blurred
3
0
      Visual impairment
5
0
Eye disorders SOC TOTAL
17
0
Report Run Date: 01-Jul-2015, Page 7

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Gastrointestinal disorders
   Colitis (excl infective)
      Colitis ulcerative
1
0
   Dental disorders NEC
      Tooth erosion
1
0
   Diarrhoea (excl infective)
      Diarrhoea
7
0
   Dyspeptic signs and symptoms
      Dyspepsia
2
0
   Flatulence, bloating and distension
      Abdominal distension
2
0
   Gastritis (excl infective)
      Gastritis
1
0
   Gastrointestinal and abdominal pains (excl oral and throat)
      Abdominal migraine
1
0
      Abdominal pain
5
0
      Abdominal pain lower
2
0
      Abdominal pain upper
9
0
   Gastrointestinal atonic and hypomotility disorders NEC
      Constipation
2
0
      Gastrooesophageal reflux disease
2
0
      Impaired gastric emptying
1
0
   Gastrointestinal disorders NEC
      Gastric disorder
1
0
      Gastrointestinal disorder
2
0
   Gastrointestinal signs and symptoms NEC
      Abdominal discomfort
3
0
   Gastrointestinal spastic and hypermotility disorders
      Irritable bowel syndrome
1
0
   Nausea and vomiting symptoms
      Nausea
84
0
      Regurgitation
1
0
      Vomiting
17
0
   Non-site specific gastrointestinal haemorrhages
      Gastrointestinal haemorrhage
1
0
      Haematemesis
1
0
   Oral soft tissue disorders NEC
      Cheilitis
1
0
   Pancreatic disorders NEC
      Pancreatic disorder
1
0
   Stomatitis and ulceration
      Mouth ulceration
1
0
Gastrointestinal disorders SOC TOTAL
150
0
Report Run Date: 01-Jul-2015, Page 8

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
General disorders
   Asthenic conditions
      Asthenia
10
0
      Chronic fatigue syndrome
11
0
      Decreased activity
1
0
      Fatigue
60
0
      Malaise
25
0
   Febrile disorders
      Pyrexia
7
0
   Feelings and sensations NEC
      Chills
1
0
      Feeling abnormal
2
0
      Feeling cold
3
0
      Feeling hot
6
0
      Feeling of body temperature change
2
0
      Thirst
1
0
   Gait disturbances
      Gait disturbance
2
0
   General signs and symptoms NEC
      Condition aggravated
1
0
      Ill-defined disorder
1
0
      Influenza like illness
5
0
      Local swelling
1
0
      Peripheral swelling
7
0
      Swelling
1
0
   Injection site reactions
      Injection site bruising
3
0
      Injection site erythema
2
0
      Injection site haemorrhage
1
0
      Injection site hypoaesthesia
2
0
      Injection site irritation
1
0
      Injection site mass
4
0
      Injection site pain
3
0
      Injection site rash
2
0
      Injection site scar
1
0
      Injection site swelling
4
0
   Pain and discomfort NEC
      Chest discomfort
1
0
      Chest pain
3
0
      Discomfort
1
0
      Pain
12
0
   Ulcers NEC
      Ulcer
1
0
General disorders SOC TOTAL
188
0
Report Run Date: 01-Jul-2015, Page 9

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Hepatic disorders
   Hepatic and hepatobiliary disorders NEC
      Hepatic cyst
1
0
      Liver disorder
1
0
   Hepatic enzymes and function abnormalities
      Hepatic function abnormal
1
0
Hepatic disorders SOC TOTAL
3
0
Report Run Date: 01-Jul-2015, Page 10

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Immune system disorders
   Allergic conditions NEC
      Hypersensitivity
2
0
   Allergies to foods, food additives, drugs and other chemicals
      Food allergy
2
0
      Reaction to preservatives
1
0
   Autoimmune disorders NEC
      Autoimmune disorder
1
0
      Overlap syndrome
1
0
   Immune and associated conditions NEC
      Immune system disorder
1
0
Immune system disorders SOC TOTAL
8
0
Report Run Date: 01-Jul-2015, Page 11

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Infections
   Bacterial infections NEC
      Small intestinal bacterial overgrowth
1
0
   Candida infections
      Candida infection
1
0
   Epstein-Barr viral infections
      Infectious mononucleosis
4
0
   Eye and eyelid infections
      Hordeolum
1
0
   Herpes viral infections
      Herpes virus infection
1
0
      Herpes zoster
1
0
   Infections NEC
      Infection
1
0
      Infection susceptibility increased
1
0
   Lower respiratory tract and lung infections
      Lower respiratory tract infection
1
0
   Papilloma viral infections
      Vulvovaginal human papilloma virus infection
1
0
   Staphylococcal infections
      Furuncle
2
0
   Upper respiratory tract infections
      Nasopharyngitis
3
0
      Pharyngitis
1
0
      Tonsillitis
2
0
   Viral infections NEC
      Post viral fatigue syndrome
6
0
      Viral infection
4
0
Infections SOC TOTAL
31
0
Report Run Date: 01-Jul-2015, Page 12

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Injuries
   Exposures associated with pregnancy, delivery and lactation
      Foetal exposure during pregnancy
1
0
   Maladministrations
      Inappropriate schedule of drug administration
1
0
   Non-site specific injuries NEC
      Wound
1
0
   Skin injuries NEC
      Contusion
5
0
      Dermatitis artefacta
1
0
Injuries SOC TOTAL
9
0
Report Run Date: 01-Jul-2015, Page 13

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Investigations
   Autoimmunity analyses
      Antinuclear antibody increased
1
0
   Blood counts NEC
      Blood count abnormal
1
0
   Blood gas and acid base analyses
      Blood pH increased
1
0
   Heart rate and pulse investigations
      Heart rate increased
2
0
   Investigations NEC
      Quality of life decreased
1
0
   Physical examination procedures and organ system status
      Body temperature decreased
1
0
      Body temperature increased
1
0
      Weight decreased
4
0
      Weight increased
1
0
   Platelet analyses
      Platelet count decreased
1
0
   Urinary tract function analyses NEC
      Urine output decreased
1
0
   White blood cell analyses
      White blood cell count decreased
1
0
Investigations SOC TOTAL
16
0
Report Run Date: 01-Jul-2015, Page 14

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Metabolic disorders
   Appetite disorders
      Decreased appetite
2
0
   Fat soluble vitamin deficiencies and disorders
      Vitamin D deficiency
1
0
   Food malabsorption and intolerance syndromes (excl sugar intolerance)
      Food intolerance
2
0
   General nutritional disorders NEC
      Abnormal loss of weight
1
0
      Feeding disorder
1
0
   Hyperglycaemic conditions NEC
      Hyperglycaemia
1
0
   Iron deficiencies
      Iron deficiency
1
0
   Total fluid volume decreased
      Dehydration
1
0
Metabolic disorders SOC TOTAL
10
0
Report Run Date: 01-Jul-2015, Page 15

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Muscle & tissue disorders
   Arthropathies NEC
      Arthritis
1
0
      Arthropathy
1
0
   Cartilage disorders
      Costochondritis
1
0
   Connective tissue disorders NEC
      Mixed connective tissue disease
1
0
   Joint related signs and symptoms
      Arthralgia
16
0
      Joint swelling
4
0
   Lupus erythematosus (incl subtypes)
      Lupus-like syndrome
1
0
      Systemic lupus erythematosus
3
0
   Metabolic bone disorders
      Osteoporosis
1
0
   Muscle infections and inflammations
      Myositis
1
0
   Muscle pains
      Fibromyalgia
1
0
      Myalgia
5
0
   Muscle related signs and symptoms NEC
      Muscle fatigue
1
0
      Muscle spasms
2
0
      Muscle twitching
2
0
   Muscle weakness conditions
      Muscular weakness
2
0
   Musculoskeletal and connective tissue pain and discomfort
      Back pain
4
0
      Growing pains
1
0
      Pain in extremity
42
0
   Musculoskeletal and connective tissue signs and symptoms NEC
      Growth retardation
2
0
      Musculoskeletal stiffness
1
0
   Rheumatoid arthropathies
      Juvenile idiopathic arthritis
2
0
Muscle & tissue disorders SOC TOTAL
95
0
Report Run Date: 01-Jul-2015, Page 16

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Neoplasms
   Endocrine neoplasms malignant and unspecified NEC
      Pituitary tumour
1
0
   Non-Hodgkin's lymphomas NEC
      Non-Hodgkin's lymphoma
1
1
Neoplasms SOC TOTAL
2
1
Report Run Date: 01-Jul-2015, Page 17

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Nervous system disorders
   Abnormal reflexes
      Areflexia
1
0
   Autonomic nervous system disorders
      Autonomic nervous system imbalance
1
0
   Central nervous system vascular disorders NEC
      Cerebrovascular disorder
1
0
   Coordination and balance disturbances
      Balance disorder
2
0
      Dysstasia
2
0
   Cortical dysfunction NEC
      Aphasia
1
0
   Disturbances in consciousness NEC
      Lethargy
5
0
      Loss of consciousness
5
0
      Somnolence
9
0
      Syncope
10
0
   Dyskinesias and movement disorders NEC
      Clumsiness
1
0
   Encephalitis NEC
      Encephalitis autoimmune
2
0
   Facial cranial nerve disorders
      VIIth nerve paralysis
1
0
   Headaches NEC
      Cluster headache
1
0
      Headache
77
0
      Tension headache
1
0
   Memory loss (excl dementia)
      Amnesia
1
0
      Memory impairment
4
0
   Mental impairment (excl dementia and memory loss)
      Cognitive disorder
2
0
      Disturbance in attention
4
0
   Migraine headaches
      Migraine
5
0
      Migraine without aura
1
0
   Narcolepsy and hypersomnia
      Cataplexy
2
0
      Hypersomnia
3
0
      Narcolepsy
2
0
   Neurologic visual problems NEC
      Visual field defect
2
0
   Neurological signs and symptoms NEC
      Dizziness
138
0
      Dizziness postural
1
0
      Head discomfort
1
0
      Neurological symptom
1
0
      Presyncope
1
0
   Neuromuscular disorders NEC
      Muscle contractions involuntary
1
0
   Paraesthesias and dysaesthesias
      Hypoaesthesia
9
0
      Paraesthesia
3
0
   Paralysis and paresis (excl cranial nerve)
Report Run Date: 01-Jul-2015, Page 18

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Nervous system disorders
Nervous system disorders cont'd
      Paralysis
1
0
   Seizures and seizure disorders NEC
      Seizure
2
0
      Seizure like phenomena
1
0
      Status epilepticus
1
0
   Speech and language abnormalities
      Dysarthria
1
0
   Spinal cord and nerve root disorders NEC
      Spinal cord oedema
1
0
   Tremor (excl congenital)
      Tremor
5
0
Nervous system disorders SOC TOTAL
313
0
Report Run Date: 01-Jul-2015, Page 19

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Psychiatric disorders
   Anxiety symptoms
      Anxiety
1
0
      Nervousness
1
0
   Behaviour and socialisation disturbances
      Disturbance in social behaviour
1
0
   Confusion and disorientation
      Disorientation
2
0
   Depressive disorders
      Depression
3
0
   Dissociative states
      Dissociation
1
0
   Disturbances in initiating and maintaining sleep
      Insomnia
2
0
      Middle insomnia
1
0
   Mood alterations with depressive symptoms
      Depressed mood
1
0
   Panic attacks and disorders
      Panic attack
2
0
   Sleep disorders NEC
      Sleep disorder
2
0
   Suicidal and self-injurious behaviour
      Intentional self-injury
1
0
Psychiatric disorders SOC TOTAL
18
0
Report Run Date: 01-Jul-2015, Page 20

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Renal & urinary disorders
   Bladder and urethral symptoms
      Bladder pain
1
0
      Bladder spasm
1
0
      Dysuria
1
0
      Micturition urgency
1
0
      Pollakiuria
3
0
   Myoneurogenic bladder disorders
      Contracted bladder
1
0
      Hypertonic bladder
1
0
Renal & urinary disorders SOC TOTAL
9
0
Report Run Date: 01-Jul-2015, Page 21

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Reproductive & breast disorders
   Menstruation and uterine bleeding NEC
      Menstrual disorder
2
0
      Menstruation irregular
3
0
   Menstruation with decreased bleeding
      Amenorrhoea
2
0
      Oligomenorrhoea
1
0
   Ovarian and fallopian tube cysts and neoplasms
      Polycystic ovaries
1
0
   Vulvovaginal disorders NEC
      Vulval disorder
1
0
      Vulvar dysplasia
1
0
Reproductive & breast disorders SOC TOTAL
11
0
Report Run Date: 01-Jul-2015, Page 22

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Respiratory disorders
   Breathing abnormalities
      Dyspnoea
5
0
      Hypopnoea
1
0
   Coughing and associated symptoms
      Cough
2
0
   Nasal disorders NEC
      Epistaxis
2
0
   Pharyngeal disorders (excl infections and neoplasms)
      Tonsillar hypertrophy
1
0
   Pneumothorax and pleural effusions NEC
      Pneumothorax
1
0
   Upper respiratory tract signs and symptoms
      Oropharyngeal discomfort
1
0
      Oropharyngeal pain
8
0
      Throat tightness
1
0
Respiratory disorders SOC TOTAL
22
0
Report Run Date: 01-Jul-2015, Page 23

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Skin disorders
   Alopecias
      Alopecia
2
0
      Alopecia totalis
1
0
      Diffuse alopecia
1
0
   Apocrine and eccrine gland disorders
      Hyperhidrosis
3
0
   Bullous conditions
      Blister
1
0
   Dermal and epidermal conditions NEC
      Dry skin
1
0
      Skin discolouration
3
0
      Skin reaction
2
0
   Dermatitis and eczema
      Dermatitis allergic
1
0
      Dermatitis contact
1
0
      Dyshidrotic eczema
1
0
   Erythemas
      Erythema
1
0
      Rash erythematous
1
0
   Nail and nail bed conditions (excl infections and infestations)
      Nail discolouration
1
0
   Panniculitides
      Erythema nodosum
1
0
   Pruritus NEC
      Pruritus
3
0
      Rash pruritic
1
0
   Psoriatic conditions
      Psoriasis
1
0
   Rashes, eruptions and exanthems NEC
      Rash
12
0
      Rash generalised
2
0
      Rash macular
1
0
   Skin hypoplasias and atrophies
      Skin striae
1
0
   Urticarias
      Urticaria
1
0
Skin disorders SOC TOTAL
43
0
Report Run Date: 01-Jul-2015, Page 24

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Social circumstances
   Age related issues
      Puberty
1
0
   Disability issues
      Activities of daily living impaired
1
0
      Bedridden
1
0
      Immobile
1
0
      Impaired work ability
1
0
   Educational issues
      Educational problem
2
0
Social circumstances SOC TOTAL
7
0
Report Run Date: 01-Jul-2015, Page 25

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Surgical & medical procedures
   Vascular therapeutic procedures NEC
      Vasodilation procedure
1
0
Surgical & medical procedures SOC TOTAL
1
0
Report Run Date: 01-Jul-2015, Page 26

Case Series Drug Analysis Print
Name: Cervarix PAP
Report Run Date: 01-Jul-2015
Data Lock Date: 30-Jun-2015 19:00:15
Earliest Reaction Date: 17-Nov-2008
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Vascular disorders
   Peripheral vascular disorders NEC
      Flushing
3
0
      Hot flush
1
0
   Peripheral vasoconstriction, necrosis and vascular insufficiency
      Peripheral coldness
6
0
   Site specific vascular disorders NEC
      Pallor
1
0
   Vascular hypotensive disorders
      Hypotension
2
0
Vascular disorders SOC TOTAL
13
0
TOTAL REACTIONS FOR DRUG
991
1
TOTAL REPORTS
419
TOTAL FATAL OUTCOME REPORTS
1
Report Run Date: 01-Jul-2015, Page 27