Case Series Drug Analysis Print Name: Gardasil
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1 Report Run Date: 12-Mar-2015 Data Lock Date: 11-Mar :00:07 Earliest Reaction Date: 29-Nov-2006 MedDRA Version: MedDRA 17.1 Gardasil: Gardasil Drug Analysis Print Report Run Date: 12-Mar-2015, Page 1
2 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 Lymphadenopathy 8 0 Blood disorders SOC TOTAL 14 0 Report Run Date: 12-Mar-2015, Page 2
3 Cardiac disorders Cardiac signs and symptoms NEC Cyanosis 5 0 Palpitations 3 0 Rate and rhythm disorders NEC Postural orthostatic tachycardia syndrome 3 0 Tachycardia 5 0 Supraventricular arrhythmias Sinus arrhythmia 1 0 Cardiac disorders SOC TOTAL 17 0 Report Run Date: 12-Mar-2015, Page 3
4 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: 12-Mar-2015, Page 4
5 Endocrine disorders Thyroid hypofunction disorders Hypothyroidism 1 0 Endocrine disorders SOC TOTAL 1 0 Report Run Date: 12-Mar-2015, Page 5
6 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 3 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 6 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 29 0 Visual impairment 9 0 Eye disorders SOC TOTAL 82 0 Report Run Date: 12-Mar-2015, Page 6
7 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 13 0 Dyspeptic signs and symptoms Dyspepsia 2 0 Flatulence, bloating and distension Abdominal distension 1 0 Gastritis (excl infective) Gastritis 2 0 Reflux gastritis 1 0 Gastrointestinal and abdominal pains (excl oral and throat) Abdominal pain 22 0 Abdominal pain lower 3 0 Abdominal pain upper 27 0 Abdominal tenderness 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 8 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 Retching 3 0 Vomiting Vomiting projectile 1 0 Non-site specific gastrointestinal haemorrhages Haematemesis 2 0 Oral soft tissue pain and paraesthesia Paraesthesia oral 6 0 Oral soft tissue swelling and oedema Lip swelling 4 0 Stomatitis and ulceration Mouth ulceration 1 0 Tongue signs and symptoms Swollen tongue 2 0 Gastrointestinal disorders SOC TOTAL Report Run Date: 12-Mar-2015, Page 7
8 General disorders Asthenic conditions Asthenia 29 0 Chronic fatigue syndrome 1 0 Fatigue 80 0 Malaise Body temperature altered Temperature regulation disorder 1 0 Febrile disorders Pyrexia 71 0 Feelings and sensations NEC Chills 10 0 Feeling abnormal 10 0 Feeling cold 9 0 Feeling hot 37 0 Feeling jittery 1 0 Feeling of body temperature change 4 0 Gait disturbances Abasia 1 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 55 0 Swelling 4 0 Inflammations Inflammation 4 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 1 0 Injection site mass 8 0 Injection site movement impairment 1 0 Injection site nerve damage 1 0 Injection site oedema 1 0 Injection site pain 21 0 Injection site pruritus 6 0 Injection site rash 1 0 Injection site reaction 1 0 Injection site swelling 19 0 Injection site warmth 2 0 Mass conditions NEC Mass 1 0 Oedema NEC Face oedema 1 0 Localised oedema 1 0 Oedema peripheral 4 0 Report Run Date: 12-Mar-2015, Page 8
9 General disorders General disorders cont'd Pain and discomfort NEC Chest discomfort 9 0 Chest pain 6 0 Discomfort 7 0 Pain 26 0 Tenderness 3 0 Therapeutic and nontherapeutic responses Drug ineffective 1 0 Immediate post-injection reaction 1 0 Trophic disorders Atrophy 1 0 General disorders SOC TOTAL Report Run Date: 12-Mar-2015, Page 9
10 Hepatic disorders Hepatic and hepatobiliary disorders NEC Liver disorder 1 0 Hepatic disorders SOC TOTAL 1 0 Report Run Date: 12-Mar-2015, Page 10
11 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 2 0 Immune and associated conditions NEC Immune system disorder 3 0 Immune system disorders SOC TOTAL 27 0 Report Run Date: 12-Mar-2015, Page 11
12 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 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 31 0 Report Run Date: 12-Mar-2015, Page 12
13 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 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 14 0 Report Run Date: 12-Mar-2015, Page 13
14 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 9 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 42 0 Report Run Date: 12-Mar-2015, Page 14
15 Metabolic disorders Appetite disorders Appetite disorder 1 0 Decreased appetite 12 0 Calcium metabolism disorders Tetany 1 0 Diabetes mellitus (incl subtypes) Type 1 diabetes mellitus 3 0 Diabetic complications NEC Diabetic ketoacidosis 1 0 General nutritional disorders NEC 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 23 0 Report Run Date: 12-Mar-2015, Page 15
16 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 32 0 Joint stiffness 2 0 Joint swelling 4 0 Muscle pains Myalgia 13 0 Muscle related signs and symptoms NEC Muscle fatigue 1 0 Muscle spasms 5 0 Muscle tightness 2 0 Muscle twitching 5 0 Muscle tone abnormalities Muscle rigidity 7 0 Muscle weakness conditions Muscular weakness 13 0 Musculoskeletal and connective tissue pain and discomfort Back pain 5 0 Limb discomfort 9 0 Musculoskeletal discomfort 1 0 Musculoskeletal pain 5 0 Neck pain 7 0 Pain in extremity 73 0 Musculoskeletal and connective tissue signs and symptoms NEC Back disorder 1 0 Mobility decreased 3 0 Musculoskeletal stiffness 14 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 Report Run Date: 12-Mar-2015, Page 16
17 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: 12-Mar-2015, Page 17
18 Nervous system disorders Abnormal reflexes Areflexia 2 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 1 0 Dysstasia 2 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 37 0 Loss of consciousness 8 0 Somnolence 20 0 Syncope Dyskinesias and movement disorders NEC Dyskinesia 16 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 Sinus headache 1 0 Tension headache 1 0 Memory loss (excl dementia) Amnesia 2 0 Memory impairment 4 0 Mental impairment (excl dementia and memory loss) Disturbance in attention 3 0 Mental impairment 1 0 Migraine headaches Migraine 8 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 Nervous system disorder 1 0 Neurological signs and symptoms NEC Dizziness Report Run Date: 12-Mar-2015, Page 18
19 Nervous system disorders Nervous system disorders cont'd Dizziness postural 1 0 Hyporesponsive to stimuli 1 0 Myoclonus 1 0 Presyncope 6 0 Slow response to stimuli 2 0 Unresponsive to stimuli 11 0 Paraesthesias and dysaesthesias Burning sensation 2 0 Hypoaesthesia 32 0 Paraesthesia 47 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 Convulsion 16 0 Epilepsy 2 0 Seizure anoxic 1 0 Seizure like phenomena 2 0 Tonic clonic movements 2 0 Sensory abnormalities NEC Complex regional pain syndrome 1 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 35 0 Nervous system disorders SOC TOTAL Report Run Date: 12-Mar-2015, Page 19
20 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: 12-Mar-2015, Page 20
21 Psychiatric disorders Abnormal behaviour NEC Abnormal behaviour 4 0 Anxiety symptoms Agitation 2 0 Anxiety 6 0 Behaviour and socialisation disturbances Aggression 1 0 Paranoia 2 0 Personality change 1 0 Bipolar disorders Bipolar disorder 1 0 Confusion and disorientation Confusional state 7 0 Disorientation 5 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 4 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 1 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 Psychiatric disorders SOC TOTAL 58 0 Report Run Date: 12-Mar-2015, Page 21
22 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: 12-Mar-2015, Page 22
23 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: 12-Mar-2015, Page 23
24 Respiratory disorders Breathing abnormalities Dyspnoea 23 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 77 0 Report Run Date: 12-Mar-2015, Page 24
25 Skin disorders Acnes Acne 2 0 Alopecias Alopecia 10 0 Diffuse alopecia 1 0 Angioedemas Angioedema 2 0 Swelling face 9 0 Apocrine and eccrine gland disorders Cold sweat 26 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 29 0 Generalised erythema 1 0 Palmar erythema 1 0 Rash erythematous 11 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 27 0 Pruritus generalised 3 0 Rash pruritic 8 0 Purpura and related conditions Petechiae 1 0 Purpura 1 0 Rashes, eruptions and exanthems NEC Rash 55 0 Rash generalised 10 0 Rash macular 9 0 Rash maculo-papular 1 0 Skin and subcutaneous conditions NEC Skin mass 1 0 Report Run Date: 12-Mar-2015, Page 25
26 Skin disorders Skin disorders cont'd Skin hyperplasias and hypertrophies Skin hypertrophy 1 0 Urticarias Urticaria 44 0 Skin disorders SOC TOTAL Report Run Date: 12-Mar-2015, Page 26
27 Social circumstances Disability issues Activities of daily living impaired 3 0 Physical disability 1 0 Educational issues Educational problem 1 0 Social circumstances SOC TOTAL 5 0 Report Run Date: 12-Mar-2015, Page 27
28 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: 12-Mar-2015, Page 28
29 Vascular disorders Non-site specific embolism and thrombosis Thrombosis 1 0 Peripheral vascular disorders NEC Flushing 14 0 Peripheral vasoconstriction, necrosis and vascular insufficiency Peripheral coldness 15 0 Site specific vascular disorders NEC Pallor 72 0 Vascular hypertensive disorders NEC Hypertension 1 0 Vascular hypotensive disorders Hypotension 6 0 Orthostatic hypotension 1 0 Vascular disorders SOC TOTAL TOTAL REACTIONS FOR DRUG TOTAL REPORTS 1440 TOTAL FATAL OUTCOME REPORTS 2 Report Run Date: 12-Mar-2015, Page 29
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