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: 13-Oct-2009
MedDRA Version:
MedDRA 18.0
HPV after 31st July
Administration before 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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Blood disorders
   Anaemias NEC
      Anaemia
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: 13-Oct-2009
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Ear disorders
   Hearing losses
      Deafness
1
0
Ear disorders SOC TOTAL
1
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Gastrointestinal disorders
   Gastric ulcers and perforation
      Gastritis erosive
1
0
   Gastrointestinal and abdominal pains (excl oral and throat)
      Abdominal pain upper
1
0
   Nausea and vomiting symptoms
      Vomiting
1
0
Gastrointestinal disorders SOC TOTAL
3
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
General disorders
   Asthenic conditions
      Asthenia
3
0
      Fatigue
4
0
      Malaise
3
0
   Febrile disorders
      Pyrexia
2
0
   Feelings and sensations NEC
      Feeling abnormal
1
0
      Thirst
1
0
   Gait disturbances
      Abasia
1
0
      Gait disturbance
1
0
   General signs and symptoms NEC
      General physical health deterioration
1
0
      Influenza like illness
1
0
   Pain and discomfort NEC
      Pain
6
0
General disorders SOC TOTAL
24
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
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: 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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Infections
   Infections NEC
      Infection susceptibility increased
1
0
   Viral infections NEC
      Post viral fatigue syndrome
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Investigations
   Endocrine analyses and imaging NEC
      Hormone level abnormal
1
0
   Physical examination procedures and organ system status
      Weight decreased
2
0
Investigations SOC TOTAL
3
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Metabolic disorders
   Diabetes mellitus (incl subtypes)
      Type 1 diabetes mellitus
1
0
Metabolic disorders SOC TOTAL
1
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Muscle & tissue disorders
   Joint related signs and symptoms
      Arthralgia
2
0
      Joint stiffness
1
0
   Muscle pains
      Myalgia
1
0
   Muscle related signs and symptoms NEC
      Muscle spasms
1
0
      Muscle twitching
1
0
   Musculoskeletal and connective tissue pain and discomfort
      Pain in extremity
2
0
   Musculoskeletal and connective tissue signs and symptoms NEC
      Back disorder
1
0
      Musculoskeletal stiffness
1
0
Muscle & tissue disorders SOC TOTAL
10
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Nervous system disorders
   Coordination and balance disturbances
      Coordination abnormal
1
0
   Cortical dysfunction NEC
      Aphasia
1
0
   Disturbances in consciousness NEC
      Lethargy
2
0
      Somnolence
1
0
      Syncope
3
0
   Dyskinesias and movement disorders NEC
      Hypokinesia
1
0
   Headaches NEC
      Headache
2
0
   Nervous system disorders NEC
      Nervous system disorder
1
0
   Neurologic visual problems NEC
      Visual field defect
1
0
   Neurological signs and symptoms NEC
      Dizziness
1
0
   Paraesthesias and dysaesthesias
      Hypoaesthesia
1
0
      Paraesthesia
1
0
   Seizures and seizure disorders NEC
      Seizure
2
0
   Sensory abnormalities NEC
      Complex regional pain syndrome
1
0
      Sensory loss
1
0
   Speech and language abnormalities
      Aphonia
1
0
Nervous system disorders SOC TOTAL
21
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Psychiatric disorders
   Anxiety symptoms
      Anxiety
1
0
   Disturbances in initiating and maintaining sleep
      Insomnia
1
0
   Emotional and mood disturbances NEC
      Irritability
1
0
   Mood alterations with depressive symptoms
      Depressive symptom
1
0
Psychiatric disorders SOC TOTAL
4
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Renal & urinary disorders
   Urinary tract signs and symptoms NEC
      Polyuria
1
0
Renal & urinary disorders SOC TOTAL
1
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Reproductive & breast disorders
   Menstruation and uterine bleeding NEC
      Dysmenorrhoea
1
0
      Menstruation irregular
1
0
   Menstruation with decreased bleeding
      Amenorrhoea
2
0
      Menstruation delayed
1
0
   Menstruation with increased bleeding
      Menorrhagia
1
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
9
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Respiratory disorders
   Breathing abnormalities
      Dyspnoea
1
0
   Coughing and associated symptoms
      Cough
1
0
   Upper respiratory tract signs and symptoms
      Oropharyngeal pain
2
0
Respiratory disorders SOC TOTAL
4
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Skin disorders
   Apocrine and eccrine gland disorders
      Hyperhidrosis
1
0
   Dermal and epidermal conditions NEC
      Skin discolouration
1
0
Skin disorders SOC TOTAL
2
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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Social circumstances
   Disability issues
      Bedridden
1
0
Social circumstances SOC TOTAL
1
0
Report Run Date: 01-Jul-2015, Page 18

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: 13-Oct-2009
MedDRA Version: MedDRA 18.0
Reaction Name
Total Fatal
Vascular disorders
   Site specific vascular disorders NEC
      Pallor
1
0
Vascular disorders SOC TOTAL
1
0
TOTAL REACTIONS FOR DRUG
91
0
TOTAL REPORTS
15
Report Run Date: 01-Jul-2015, Page 19