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: HPV after 31st July 2012
Report Run Date:
01-Jul-2015
Data Lock Date:
26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version:
MedDRA 18.0
HPV after 31st July
Administration after 09/2012
2012:
Report Run Date: 01-Jul-2015, Page 1

 
Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Blood disorders
   Lymphatic system disorders NEC
      Lymphadenopathy
1
0
Blood disorders SOC TOTAL
1
0
Report Run Date: 01-Jul-2015, Page 2

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Cardiac disorders
   Rate and rhythm disorders NEC
      Postural orthostatic tachycardia syndrome
1
0
Cardiac disorders SOC TOTAL
1
0
Report Run Date: 01-Jul-2015, Page 3

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Eye disorders
   Choroid and vitreous structural change, deposit and degeneration
      Vitreous floaters
1
0
   Ocular disorders NEC
      Eye disorder
1
0
      Eye pain
1
0
      Eye swelling
1
0
      Ocular discomfort
1
0
   Visual disorders NEC
      Visual impairment
1
0
Eye disorders SOC TOTAL
6
0
Report Run Date: 01-Jul-2015, Page 4

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Gastrointestinal disorders
   Gastrointestinal and abdominal pains (excl oral and throat)
      Abdominal pain
1
0
      Abdominal pain upper
2
0
   Nausea and vomiting symptoms
      Nausea
12
0
      Vomiting
4
0
   Oral soft tissue swelling and oedema
      Lip swelling
1
0
   Tongue signs and symptoms
      Swollen tongue
1
0
Gastrointestinal disorders SOC TOTAL
21
0
Report Run Date: 01-Jul-2015, Page 5

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
General disorders
   Asthenic conditions
      Chronic fatigue syndrome
1
0
      Fatigue
3
0
      Malaise
8
0
   Febrile disorders
      Pyrexia
19
0
   Feelings and sensations NEC
      Chills
2
0
      Feeling abnormal
1
0
      Feeling hot
1
0
   Gait disturbances
      Gait disturbance
1
0
   General signs and symptoms NEC
      Peripheral swelling
2
0
   Injection site reactions
      Injection site hypoaesthesia
1
0
      Injection site pain
1
0
      Injection site swelling
2
0
   Pain and discomfort NEC
      Chest discomfort
1
0
      Chest pain
2
0
      Pain
4
0
General disorders SOC TOTAL
49
0
Report Run Date: 01-Jul-2015, Page 6

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Immune system disorders
   Anaphylactic responses
      Anaphylactic reaction
2
0
Immune system disorders SOC TOTAL
2
0
Report Run Date: 01-Jul-2015, Page 7

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Infections
   Abdominal and gastrointestinal infections
      Appendicitis
1
0
   Eye and eyelid infections
      Hordeolum
1
0
Infections SOC TOTAL
2
0
Report Run Date: 01-Jul-2015, Page 8

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Injuries
   Maladministrations
      Drug administered at inappropriate site
1
0
Injuries SOC TOTAL
1
0
Report Run Date: 01-Jul-2015, Page 9

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Investigations
   Physical examination procedures and organ system status
      Body temperature increased
1
0
   Reproductive hormone analyses
      Oestradiol decreased
1
0
Investigations SOC TOTAL
2
0
Report Run Date: 01-Jul-2015, Page 10

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Metabolic disorders
   Appetite disorders
      Decreased appetite
1
0
   General nutritional disorders NEC
      Abnormal loss of weight
1
0
      Feeding disorder
1
0
Metabolic disorders SOC TOTAL
3
0
Report Run Date: 01-Jul-2015, Page 11

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Muscle & tissue disorders
   Joint related signs and symptoms
      Arthralgia
2
0
      Joint effusion
1
0
   Muscle pains
      Myalgia
2
0
   Muscle related signs and symptoms NEC
      Muscle spasms
1
0
   Muscle weakness conditions
      Muscular weakness
1
0
   Musculoskeletal and connective tissue pain and discomfort
      Back pain
2
0
      Limb discomfort
1
0
      Pain in extremity
6
0
Muscle & tissue disorders SOC TOTAL
16
0
Report Run Date: 01-Jul-2015, Page 12

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Nervous system disorders
   Disturbances in consciousness NEC
      Lethargy
1
0
      Somnolence
2
0
      Syncope
4
0
   Dyskinesias and movement disorders NEC
      Hypokinesia
2
0
   Facial cranial nerve disorders
      VIIth nerve paralysis
1
0
   Headaches NEC
      Headache
12
0
   Narcolepsy and hypersomnia
      Narcolepsy
1
0
   Neurological signs and symptoms NEC
      Dizziness
7
0
   Paraesthesias and dysaesthesias
      Hyperaesthesia
2
0
      Hypoaesthesia
2
0
      Paraesthesia
2
0
   Seizures and seizure disorders NEC
      Seizure
2
0
   Sensory abnormalities NEC
      Sensory disturbance
2
0
   Sleep disturbances NEC
      Sudden onset of sleep
1
0
   Tremor (excl congenital)
      Tremor
1
0
Nervous system disorders SOC TOTAL
42
0
Report Run Date: 01-Jul-2015, Page 13

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Psychiatric disorders
   Abnormal behaviour NEC
      Abnormal behaviour
1
0
   Anxiety symptoms
      Agitation
1
0
      Anxiety
2
0
   Behaviour and socialisation disturbances
      Aggression
1
0
      Paranoia
1
0
   Fear symptoms and phobic disorders (incl social phobia)
      Fear of death
1
0
   Mood disorders NEC
      Listless
1
0
   Psychotic disorder NEC
      Psychotic disorder
1
0
   Sleep disorders NEC
      Sleep disorder
1
0
Psychiatric disorders SOC TOTAL
10
0
Report Run Date: 01-Jul-2015, Page 14

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Reproductive & breast disorders
   Cervix disorders NEC
      Uterine cervix atrophy
1
0
   Menstruation with decreased bleeding
      Amenorrhoea
1
0
      Menstruation delayed
1
0
Reproductive & breast disorders SOC TOTAL
3
0
Report Run Date: 01-Jul-2015, Page 15

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Respiratory disorders
   Breathing abnormalities
      Dyspnoea
3
0
      Respiratory distress
1
0
   Bronchospasm and obstruction
      Wheezing
1
0
   Coughing and associated symptoms
      Cough
1
0
   Upper respiratory tract signs and symptoms
      Choking sensation
1
0
      Oropharyngeal pain
3
0
      Throat irritation
1
0
      Throat tightness
1
0
Respiratory disorders SOC TOTAL
12
0
Report Run Date: 01-Jul-2015, Page 16

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Skin disorders
   Alopecias
      Alopecia totalis
1
0
   Angioedemas
      Swelling face
2
0
   Apocrine and eccrine gland disorders
      Cold sweat
1
0
      Hyperhidrosis
1
0
   Bullous conditions
      Erythema multiforme
1
0
   Dermal and epidermal conditions NEC
      Pain of skin
2
0
      Skin discolouration
2
0
   Dermatitis and eczema
      Dermatitis allergic
1
0
   Erythemas
      Erythema
2
0
   Photosensitivity and photodermatosis conditions
      Photosensitivity reaction
2
0
   Pruritus NEC
      Pruritus generalised
1
0
   Purpura and related conditions
      Petechiae
1
0
   Rashes, eruptions and exanthems NEC
      Rash
4
0
      Rash generalised
2
0
   Urticarias
      Urticaria
2
0
Skin disorders SOC TOTAL
25
0
Report Run Date: 01-Jul-2015, Page 17

Case Series Drug Analysis Print
Name: HPV after 31st July 2012
Report Run Date: 01-Jul-2015
Data Lock Date: 26-Jun-2015 19:00:15
Earliest Reaction Date: 21-Sep-2012
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Vascular disorders
   Peripheral vascular disorders NEC
      Flushing
1
0
   Peripheral vasoconstriction, necrosis and vascular insufficiency
      Peripheral coldness
1
0
Vascular disorders SOC TOTAL
2
0
TOTAL REACTIONS FOR DRUG
198
0
TOTAL REPORTS
61
Report Run Date: 01-Jul-2015, Page 18