Drug Analysis Print Drug name: HUMAN PAPILLOMA VIRUS

Transcription

1 Jump to first report page Report type: Total number of reactions*: 9742 Total number of ADR reports: 1601 Total number of fatal ADR reports: 2 Products included in this print - Multi active products (PBGs): CERVARIX GARDASIL NONAVALENT HPV L1 VLP VACCINE (V503) SILGARD *It is important to note that one report may contain one or more reactions. Page 1 of 51

2 System Organ Class All Fatal All Fatal All Fatal Blood disorders Cardiac disorders Congenital disorders Ear disorders Endocrine disorders Eye disorders Gastrointestinal disorders General disorders Hepatic disorders Immune system disorders Infections Injuries Investigations Metabolic disorders Muscle & tissue disorders Neoplasms Nervous system disorders Pregnancy conditions Psychiatric disorders Renal & urinary disorders Reproductive & breast disorders Respiratory disorders Skin disorders Social circumstances Surgical & medical procedures Vascular disorders TOTAL NUMBER OF REACTIONS TOTAL NUMBER OF FATAL ADR REPORTS* 0 2 2* TOTAL NUMBER OF ADR REPORTS* * *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 2 of 51

3 Glossary/Abbreviations ADR - Adverse Drug Reaction Age group - lists which age groups are included in the Drug Analysis Print either ALL, Adolescent, Adult, Child, Elderly, Infant or Neonate Data lock date - shows data on the database at this specified date and time - High Level Term - see definition of MedDRA MedDRA - this stands for Medical Dictionary for Regulatory Activities, which is the internationally agreed list of terms used for Medicines Regulation. MedDRA groups related adverse drug reaction terms in a hierarchical structure whereby the 'preferred term' () (e.g. tunnel vision) is grouped under the broader heading the 'high level term' () (e.g. visual field disorders). 'High level terms' are contained within the 'system organ class' () (e.g. eye disorders). The 'preferred term' is the most specific term on the Drug Analysis Print, while the 'system organ class' is the most general Multi active products - contain the drug of interest plus one or more other drug s (e.g. co-codamol contains paracetamol and codeine) NEC - appears in MedDRA and stands for Not Elsewhere Classified NOS - appears in MedDRA and stands for Not Otherwise Specified PBG - Product Brand Group this means drug brand name e.g. Amoxil is a PBG for the drug substance amoxicillin Products included in this print - this is a list of the products for which at least one suspected Adverse Drug Reaction (ADR) report has been received that specifies that product as a 'suspected drug' (i.e. suspected causal association with the reaction). It does not provide an exhaustive list of the products which contain the named drug substance - Preferred Term - see definition of MedDRA Reaction - defines which ADRs are included in the Drug Analysis Print either ALL, Serious or Non-Serious Reporter type - lists the reporter types which are included in the Drug Analysis Print either Patient, Health Professional or ALL (i.e. both) Report run date - the date the Drug Analysis Print was produced Route of admin - lists the route of administration of the suspect drug for which reports are included in the Drug Analysis Print, e.g. ORAL only includes reports where the suspect drug was specified as having been taken by the oral route, or ALL which includes all routes of administration products - contain only the drug substance of interest - suspected ADR reports sent in to the Yellow Card Scheme are called spontaneous reports Substance - is an active ingredient in a product Substance Variant - is a more specific substance term. A substance may have zero, one or many linked variants. For example LITHIUM is linked to the variant LITHUM CARBONATE and LITHIUM CITRATE. System Organ Class () - this is the highest level in MedDRA which groups together reactions that affect similar systems/organs in the body Page 3 of 51

4 Blood disorders Anaemia deficiencies Iron deficiency anaemia Pernicious anaemia Anaemias NEC Anaemia Anaemias haemolytic NEC Haemolytic anaemia Bleeding tendencies Increased tendency to bruise Coagulopathies Antiphospholipid syndrome Leukopenias NEC Leukopenia Lymphatic system disorders NEC Lymph node pain Lymphadenitis Lymphadenopathy Marrow depression and hypoplastic anaemias Aplastic anaemia Thrombocytopenias Immune thrombocytopenic purpura Thrombocytopenia Thrombocytopenic purpura Blood disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 4 of 51

5 Cardiac disorders Cardiac conduction disorders Atrioventricular block Cardiac disorders NEC Cardiovascular disorder Cardiac signs and symptoms NEC Cardiac discomfort Cyanosis Palpitations Ischaemic coronary artery disorders Angina pectoris Noninfectious pericarditis Pericarditis Rate and rhythm disorders NEC Arrhythmia Bradycardia Extrasystoles Postural orthostatic tachycardia syndrome Tachycardia Supraventricular arrhythmias Atrial tachycardia Supraventricular tachycardia Cardiac disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 5 of 51

6 Congenital disorders Adrenal disorders congenital Congenital adrenal gland hypoplasia Autosomal chromosomal abnormalities Trisomy Central nervous system disorders congenital NEC Meningomyelocele Syringomyelia Diaphragmatic disorders congenital Congenital diaphragmatic hernia Musculoskeletal and connective tissue disorders of limbs congenital Congenital foot malformation Developmental hip dysplasia Musculoskeletal and connective tissue disorders of skull congenital Congenital absence of cranial vault Palate disorders congenital Cleft lip and palate Pulmonary and bronchial disorders congenital Pulmonary hypoplasia Congenital disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 6 of 51

7 Ear disorders Ear disorders NEC Ear discomfort Ear disorder Ear pain Ear pruritus Hearing disorders NEC Dysacusis Hearing losses Deafness Deafness neurosensory Deafness transitory Deafness unilateral Hearing impaired Hypoacusis Sudden hearing loss Hyperacusia Hyperacusis Inner ear disorders NEC Meniere's disease Inner ear signs and symptoms Motion sickness Tinnitus Vertigo Vertigo positional Ear disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 7 of 51

8 Endocrine disorders Acute and chronic thyroiditis Autoimmune thyroiditis Anterior pituitary hyperfunction Hyperprolactinaemia Endocrine abnormalities of gonadal function NEC Oestrogen deficiency Endocrine abnormalities of puberty Precocious puberty Thyroid disorders NEC Goitre Thyroid hyperfunction disorders Hyperthyroidism Thyroid hypofunction disorders Hypothyroidism Endocrine disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 8 of 51

9 Eye disorders Blindness (excl colour blindness) Blindness Blindness transient Night blindness Conjunctival infections, irritations and inflammations Conjunctivitis allergic Eyelid movement disorders Blepharospasm Iris and ciliary body structural change, deposit and degeneration Iris disorder Iris and uveal tract infections, irritations and inflammations Iritis Lacrimation disorders Dry eye Lacrimation increased Lid, lash and lacrimal infections, irritations and inflammations Eyelid oedema Ocular disorders NEC Dark circles under eyes Eye disorder Eye oedema Eye pain Eye swelling Eyelid pain Ocular discomfort Ocular icterus Ocular infections, inflammations and associated manifestations Eye allergy Eye inflammation Eye irritation Eye pruritus Ocular hyperaemia Ocular nerve and muscle disorders Eye movement disorder Heterophoria Ocular sensation disorders Abnormal sensation in eye Photophobia Optic disc abnormalities NEC Papilloedema Partial vision loss *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 9 of 51

10 Reaction Name Eye disorders cont'd All Fatal All Fatal All Fatal Visual acuity reduced Pupil disorders Mydriasis Pupils unequal Retinal structural change, deposit and degeneration Maculopathy Retinal pigment epitheliopathy Retinal, choroid and vitreous infections and inflammations Retinal vasculitis Structural change, deposit and degeneration of eye NEC Exophthalmos Visual disorders NEC Diplopia Photopsia Vision blurred Visual impairment Eye disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 10 of 51

11 Gastrointestinal disorders Abdominal findings abnormal Gastrointestinal sounds abnormal Anal and rectal signs and symptoms Anal pruritus Anorectal discomfort Benign oral cavity neoplasms Mouth cyst Colitis (excl infective) Colitis ulcerative Crohn's disease Dental disorders NEC Loose tooth Periodontal disease Tooth deposit Tooth disorder Dental pain and sensation disorders Toothache Diarrhoea (excl infective) Diarrhoea Diarrhoea haemorrhagic Dyspeptic signs and symptoms Dyspepsia Eructation Faecal abnormalities NEC Abnormal faeces Faeces discoloured Faeces hard Flatulence, bloating and distension Abdominal distension Flatulence Gastritis (excl infective) Gastritis Gastrointestinal and abdominal pains (excl oral and throat) Abdominal migraine Abdominal pain Abdominal pain lower Abdominal pain upper Gastrointestinal pain Gastrointestinal atonic and hypomotility disorders NEC Constipation Gastrooesophageal reflux disease *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 11 of 51

12 Reaction Name Gastrointestinal disorders cont'd All Fatal All Fatal All Fatal Impaired gastric emptying Gastrointestinal disorders NEC Functional gastrointestinal disorder Gastrointestinal disorder Gastrointestinal dyskinetic disorders Change of bowel habit Gastrointestinal motility disorder Gastrointestinal inflammatory disorders NEC Gastrointestinal tract irritation Gastrointestinal signs and symptoms NEC Abdominal discomfort Abdominal symptom Breath odour Dysphagia Gastrointestinal spastic and hypermotility disorders Defaecation urgency Irritable bowel syndrome Gingival haemorrhages Gingival bleeding Haemorrhoids and gastrointestinal varices (excl oesophageal) Haemorrhoids Intestinal haemorrhages Rectal haemorrhage Malabsorption syndromes Coeliac disease Nausea and vomiting symptoms Nausea Vomiting Vomiting projectile Non-site specific gastrointestinal haemorrhages Haematemesis Haematochezia Oral dryness and saliva altered Dry mouth Salivary hypersecretion Oral soft tissue disorders NEC Cheilitis Oral disorder Oral soft tissue haemorrhages Mouth haemorrhage Oral soft tissue pain and paraesthesia Lip pain *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 12 of 51

13 Reaction Name Gastrointestinal disorders cont'd All Fatal All Fatal All Fatal Odynophagia Oral pain Paraesthesia oral Oral soft tissue signs and symptoms Hypoaesthesia oral Oral discomfort Oral mucosal blistering Oral mucosal eruption Oral soft tissue swelling and oedema Lip swelling Mouth swelling Salivary gland disorders NEC Salivary gland calculus Stomatitis and ulceration Aphthous stomatitis Mouth ulceration Stomatitis Tongue disorders Tongue ulceration Tongue signs and symptoms Swollen tongue Tongue coated Gastrointestinal disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 13 of 51

14 General disorders Application and instillation site reactions Application site erythema Asthenic conditions Asthenia Chronic fatigue syndrome Decreased activity Fatigue Malaise Sluggishness Body temperature altered Temperature regulation disorder Device malfunction events NEC Undersensing Febrile disorders Pyrexia Feelings and sensations NEC Chills Feeling abnormal Feeling cold Feeling drunk Feeling hot Feeling of body temperature change Hunger Sensation of foreign body Sense of oppression Temperature intolerance Thirst Gait disturbances Abasia Gait disturbance General signs and symptoms NEC Condition aggravated Crying Exercise tolerance decreased Foaming at mouth General physical health deterioration General symptom Induration Influenza like illness Local reaction Local swelling *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 14 of 51

15 Reaction Name General disorders cont'd All Fatal All Fatal All Fatal Peripheral swelling Secretion discharge Swelling Healing abnormal NEC Impaired healing Inflammations Inflammation Injection site reactions Injection site bruising Injection site discomfort Injection site eczema Injection site erythema Injection site extravasation Injection site granuloma Injection site haematoma Injection site induration Injection site inflammation Injection site mass Injection site nodule Injection site pain Injection site paraesthesia Injection site pruritus Injection site rash Injection site reaction Injection site swelling Injection site urticaria Injection site vesicles Injection site warmth Mass conditions NEC Cyst Nodule Mucosal findings abnormal Mucous membrane disorder Oedema mucosal Oedema NEC Face oedema Generalised oedema Localised oedema Oedema Oedema peripheral Pain and discomfort NEC Chest discomfort *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 15 of 51

16 Reaction Name General disorders cont'd All Fatal All Fatal All Fatal Chest pain Discomfort Facial pain Non-cardiac chest pain Pain Tenderness Therapeutic and nontherapeutic responses Adverse event Drug ineffective Drug intolerance Trophic disorders Dysplasia Vaccination site reactions Extensive swelling of vaccinated limb Vaccination site bruising Vaccination site erythema Vaccination site granuloma Vaccination site induration Vaccination site inflammation Vaccination site nodule Vaccination site pain Vaccination site pruritus Vaccination site rash Vaccination site reaction Vaccination site swelling Vaccination site warmth General disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 16 of 51

17 Hepatic disorders Cholestasis and jaundice Jaundice Hepatic and hepatobiliary disorders NEC Liver disorder Hepatobiliary signs and symptoms Hepatomegaly Hepatocellular damage and hepatitis NEC Autoimmune hepatitis Liver injury Hepatic disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 17 of 51

18 Immune system disorders Allergic conditions NEC Allergy to animal Allergy to arthropod bite Allergy to metals Allergy to plants Hypersensitivity Allergies to foods, food additives, drugs and other chemicals Drug hypersensitivity Food allergy Perfume sensitivity Reaction to drug excipients Anaphylactic responses Anaphylactic reaction Anaphylactic shock Atopic disorders House dust allergy Seasonal allergy Autoimmune disorders NEC Autoimmune disorder Immune and associated conditions NEC Decreased immune responsiveness Immune system disorder Immunodeficiency disorders NEC Immunodeficiency Immunosuppression Immune system disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 18 of 51

19 Infections Abdominal and gastrointestinal infections Abdominal infection Appendicitis Gastrointestinal infection Pancreas infection Bacterial infections NEC Bacterial infection Folliculitis Bone and joint infections Arthritis infective Intervertebral discitis Central nervous system and spinal infections Encephalitis Meningitis Myelitis Spinal cord infection Chlamydial infections Pneumonia chlamydial Clostridia infections Clostridial infection Dental and oral soft tissue infections Abscess oral Gingivitis Periodontitis Ear infections Ear infection Otitis externa Otitis media Otitis media acute Enteroviral infections NEC Meningitis enteroviral Epstein-Barr viral infections Infectious mononucleosis Eye and eyelid infections Chorioretinitis Conjunctivitis Eye infection Hordeolum Female reproductive tract infections Pelvic inflammatory disease Vaginal infection *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 19 of 51

20 Reaction Name Infections cont'd All Fatal All Fatal All Fatal Fungal infections NEC Fungal infection Fungal skin infection Vulvovaginal mycotic infection Herpes viral infections Genital herpes Herpes simplex Herpes virus infection Herpes zoster Oral herpes Infections NEC Abscess Infection Infection susceptibility increased Injection site abscess Injection site infection Vaccination site infection Vestibulitis Influenza viral infections Influenza Lower respiratory tract and lung infections Pneumonia Mycoplasma infections Pneumonia mycoplasmal Skin structures and soft tissue infections Impetigo Skin infection Subcutaneous abscess Streptococcal infections Pharyngitis streptococcal Streptococcal infection Upper respiratory tract infections Chronic sinusitis Nasopharyngitis Pharyngitis Rhinitis Sinusitis Tonsillitis Urinary tract infections Cystitis Urinary tract infection Viral infections NEC *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 20 of 51

21 Reaction Name Infections cont'd All Fatal All Fatal All Fatal Post viral fatigue syndrome Vestibular neuronitis Viral infection Infections TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 21 of 51

22 Injuries Accidental exposures to product Accidental exposure to product Cerebral injuries NEC Concussion Exposures associated with pregnancy, delivery and lactation Exposure during pregnancy Foetal exposure during pregnancy Maternal exposure before pregnancy Fractures and dislocations NEC Fracture Joint dislocation Heat injuries (excl thermal burns) Heat stroke Maladministrations Drug administered at inappropriate site Drug administration error Extra dose administered Inappropriate schedule of drug administration Incorrect dose administered Incorrect route of drug administration Wrong technique in drug usage process Medication errors NEC Vaccination error Muscle, tendon and ligament injuries Ligament injury Nerve injuries NEC Nerve injury Non-site specific injuries NEC Fall Injury Wound Off label uses Off label use Pathways and sources of exposure Exposure via direct contact Poisoning and toxicity Metal poisoning Product use issues NEC Drug administered to patient of inappropriate age Skin injuries NEC Contusion *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 22 of 51

23 Reaction Name Injuries cont'd All Fatal All Fatal All Fatal Scar Skin wound Underdoses NEC Underdose Vaccination related complications Vaccination complication Injuries TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 23 of 51

24 Investigations Autoimmunity analyses LE cells Blood gas and acid base analyses Blood lactic acid Carbohydrate tolerance analyses (incl diabetes) Blood glucose decreased Blood glucose increased Ear and labyrinth histopathology procedures Paracentesis ear Endocrine analyses and imaging NEC Hormone level abnormal Gastrointestinal function diagnostic procedures Gastric ph decreased Haematological analyses NEC Red blood cell sedimentation rate increased Heart rate and pulse investigations Heart rate decreased Heart rate increased Heart rate irregular Orthostatic heart rate response increased Pulse abnormal Investigations NEC Quality of life decreased Liver function analyses Alanine aminotransferase increased Gamma-glutamyltransferase increased Hepatic enzyme abnormal Hepatic enzyme increased Neurologic diagnostic procedures Pain threshold decreased Physical examination procedures and organ system status Apgar score low Body temperature abnormal Body temperature decreased Body temperature fluctuation Lymph node palpable Weight abnormal Weight decreased Weight increased Protein analyses NEC C-reactive protein increased *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 24 of 51

25 Reaction Name Investigations cont'd All Fatal All Fatal All Fatal Red blood cell analyses Haemoglobin decreased Respiratory and pulmonary function diagnostic procedures Pulmonary function test decreased Total lung capacity decreased Urinalysis NEC Blood urine present Vascular tests NEC (incl blood pressure) Blood pressure decreased Vitamin analyses Vitamin D decreased White blood cell analyses Neutrophil count decreased Neutrophil count increased White blood cell count increased Investigations TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 25 of 51

26 Metabolic disorders Appetite disorders Appetite disorder Decreased appetite Hyperphagia Increased appetite Lack of satiety Calcium metabolism disorders Calcium deficiency Diabetes mellitus (incl subtypes) Type 1 diabetes mellitus Elevated cholesterol Hypercholesterolaemia Fat soluble vitamin deficiencies and disorders Vitamin A deficiency Vitamin D deficiency Fluid intake increased Polydipsia Food malabsorption and intolerance syndromes (excl sugar intolerance) Alcohol intolerance Cow's milk intolerance Food intolerance Histamine intolerance General nutritional disorders NEC Abnormal loss of weight Overweight Weight fluctuation Weight gain poor Hyperglycaemic conditions NEC Glucose tolerance impaired Iron deficiencies Iron deficiency Metabolic disorders NEC Metabolic disorder Potassium imbalance Hypokalaemia Sugar intolerance (excl glucose intolerance) Fructose intolerance Lactose intolerance Total fluid volume decreased Dehydration *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 26 of 51

27 Reaction Name Metabolic disorders cont'd All Fatal All Fatal All Fatal Total fluid volume increased Fluid retention Vitamin deficiencies NEC Hypovitaminosis Water soluble vitamin deficiencies Vitamin B complex deficiency Vitamin B12 deficiency Metabolic disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 27 of 51

28 Muscle & tissue disorders Arthropathies NEC Arthritis Arthritis reactive Arthropathy Bone disorders NEC Bone cyst Bone disorder Medial tibial stress syndrome Bone related signs and symptoms Bone pain Coccydynia Pain in jaw Pubic pain Spinal pain Bursal disorders Bursitis Connective tissue disorders NEC Connective tissue disorder Extremity deformities Foot deformity Intervertebral disc disorders NEC Intervertebral disc protrusion Joint related disorders NEC Facet joint syndrome Hypermobility syndrome Joint contracture Joint laxity Joint lock Periarthritis Joint related signs and symptoms Arthralgia Joint crepitation Joint stiffness Joint swelling Joint warmth Lupus erythematosus (incl subtypes) Systemic lupus erythematosus Muscle infections and inflammations Myositis Muscle pains Fibromyalgia *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 28 of 51

29 Reaction Name Muscle & tissue disorders cont'd All Fatal All Fatal All Fatal Myalgia Muscle related signs and symptoms NEC Muscle atrophy Muscle disorder Muscle fatigue Muscle spasms Muscle swelling Muscle tightness Muscle twitching Muscle tone abnormalities Trismus Muscle weakness conditions Muscular weakness Musculoskeletal and connective tissue pain and discomfort Back pain Growing pains Limb discomfort Musculoskeletal chest pain Musculoskeletal discomfort Musculoskeletal pain Neck pain Pain in extremity Rheumatic disorder Musculoskeletal and connective tissue signs and symptoms NEC Mastication disorder Musculoskeletal stiffness Winged scapula Myopathies Mitochondrial myopathy acquired Myopathy Rheumatoid arthropathies Rheumatoid arthritis Soft tissue disorders NEC Fistula Fistula discharge Groin pain Spine and neck deformities Scoliosis Tendon disorders Tendon laxity Tendon pain Tendonitis *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 29 of 51

30 Reaction Name Muscle & tissue disorders cont'd All Fatal All Fatal All Fatal Tenosynovitis Trunk deformities Shoulder deformity Muscle & tissue disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 30 of 51

31 Neoplasms Neoplasms benign site unspecified NEC Fibroma Neoplasms unspecified malignancy and site unspecified NEC Granular cell tumour Neoplasm Rhabdomyosarcomas Rhabdomyosarcoma Skin neoplasms benign Anogenital warts Melanocytic naevus Skin papilloma Skin neoplasms malignant and unspecified (excl melanoma) Neoplasm skin Vaginal neoplasms benign Vulvovaginal warts Neoplasms TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 31 of 51

32 Nervous system disorders Abnormal reflexes Areflexia Hyporeflexia Absence seizures Petit mal epilepsy Acute polyneuropathies Guillain-Barre syndrome Polyneuropathy Autonomic nervous system disorders Autonomic nervous system imbalance Orthostatic intolerance Central nervous system haemorrhages and cerebrovascular accidents Cerebral haemorrhage Cerebral ischaemia Cerebral thrombosis Central nervous system vascular disorders NEC Cerebrovascular disorder Cerebrovascular venous and sinus thrombosis Intracranial venous sinus thrombosis Choreiform movements Sydenham's chorea Coordination and balance disturbances Ataxia Balance disorder Coordination abnormal Dysstasia Cortical dysfunction NEC Aphasia Dysgraphia Dementia (excl Alzheimer's type) Dementia Demyelinating disorders NEC Acute disseminated encephalomyelitis Demyelination Neuromyelitis optica Disturbances in consciousness NEC Altered state of consciousness Depressed level of consciousness Lethargy Loss of consciousness *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 32 of 51

33 Reaction Name Nervous system disorders cont'd All Fatal All Fatal All Fatal Somnolence Syncope Dyskinesias and movement disorders NEC Clumsiness Dyskinesia Fine motor delay Hyperkinesia Hypokinesia Movement disorder Psychomotor hyperactivity Tardive dyskinesia Dystonias Dystonia Opisthotonus Eye movement disorders VIth nerve paralysis Facial cranial nerve disorders Facial paresis VIIth nerve paralysis Generalised tonic-clonic seizures Generalised tonic-clonic seizure Headaches NEC Cluster headache Cold-stimulus headache Headache Sinus headache Tension headache Hypoglossal nerve disorders Hypoglossal nerve paralysis Tongue paralysis Increased intracranial pressure disorders Benign intracranial hypertension Intracranial pressure increased Lumbar spinal cord and nerve root disorders Sciatica Memory loss (excl dementia) Amnesia Memory impairment Mental impairment (excl dementia and memory loss) Cognitive disorder Disturbance in attention Migraine headaches *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 33 of 51

34 Reaction Name Nervous system disorders cont'd All Fatal All Fatal All Fatal Migraine Migraine with aura Migraine without aura Mononeuropathies Peroneal nerve palsy Motor neurone diseases Motor neurone disease Multiple sclerosis acute and progressive Multiple sclerosis Uhthoff's phenomenon Muscle tone abnormal Hypotonia Myelitis (incl infective) Myelitis transverse Narcolepsy and hypersomnia Cataplexy Hypersomnia Narcolepsy Nervous system cysts and polyps Cerebral cyst Nervous system disorders NEC Motor dysfunction Nervous system disorder Neurologic visual problems NEC Tunnel vision Visual field defect Neurological signs and symptoms NEC Dizziness Dizziness postural Head discomfort Neurological symptom Presyncope Unresponsive to stimuli Neuromuscular disorders NEC Muscle contractions involuntary Neuromyopathy Neuromuscular junction dysfunction Myasthenia gravis Olfactory nerve disorders Anosmia Parosmia Optic nerve disorders NEC *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 34 of 51

35 Reaction Name Nervous system disorders cont'd All Fatal All Fatal All Fatal Optic neuritis Paraesthesias and dysaesthesias Burning sensation Dysaesthesia Formication Hyperaesthesia Hypoaesthesia Paraesthesia Paralysis and paresis (excl cranial nerve) Diplegia Gait spastic Hemiparesis Hemiplegia Monoparesis Monoplegia Paralysis Paresis Spinal cord paralysis Partial complex seizures Dreamy state Peripheral neuropathies NEC Neuritis Neuropathy peripheral Seizures and seizure disorders NEC Atonic seizures Benign rolandic epilepsy Clonic convulsion Epilepsy Idiopathic generalised epilepsy Seizure Sensory abnormalities NEC Allodynia Complex regional pain syndrome Dysgeusia Neuralgia Restless legs syndrome Sensory disturbance Sensory loss Sleep disturbances NEC Poor quality sleep Sudden onset of sleep Speech and language abnormalities *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 35 of 51

36 Reaction Name Nervous system disorders cont'd All Fatal All Fatal All Fatal Aphonia Dysarthria Dyslalia Language disorder Speech disorder Spinal cord and nerve root disorders NEC Radicular pain Radiculopathy Structural brain disorders NEC Brain injury Cerebral atrophy White matter lesion Transient cerebrovascular events Transient ischaemic attack Tremor (excl congenital) Tremor Trigeminal disorders Trigeminal neuralgia Nervous system disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 36 of 51

37 Pregnancy conditions Abortions not specified as induced or spontaneous Abortion missed Abortions spontaneous Abortion spontaneous Gestational age and weight conditions Premature baby Labour onset and length abnormalities Prolonged rupture of membranes Placental abnormalities (excl neoplasms) Placental disorder Stillbirth and foetal death Foetal death Pregnancy conditions TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 37 of 51

38 Psychiatric disorders Abnormal behaviour NEC Abnormal behaviour Affect alterations NEC Affect lability Anxiety symptoms Anxiety Nervousness Stress Tension Behaviour and socialisation disturbances Aggression Impatience Personality change Social avoidant behaviour Cognitive and attention disorders and disturbances NEC Daydreaming Distractibility Confusion and disorientation Confusional state Disorientation Depressive disorders Depression Dysthymic disorder Major depression Dissociative states Depersonalisation Dissociation Disturbances in initiating and maintaining sleep Initial insomnia Insomnia Eating disorders NEC Food aversion Emotional and mood disturbances NEC Anger Emotional disorder Irritability Mood altered Fear symptoms and phobic disorders (incl social phobia) Claustrophobia Fear of falling Phonophobia *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 38 of 51

39 Reaction Name Psychiatric disorders cont'd All Fatal All Fatal All Fatal Social fear Fluctuating mood symptoms Mood swings Increased physical activity levels Restlessness Learning disorders Learning disorder Reading disorder Mental disorders NEC Mental disorder Mood alterations with depressive symptoms Depressed mood Mood disorders NEC Apathy Obsessive-compulsive disorders and symptoms Obsessive thoughts Obsessive-compulsive disorder Orgasmic disorders and disturbances Female orgasmic disorder Parasomnias Nightmare Perception disturbances Derealisation Hallucination Hallucination, visual Hallucinations, mixed Personality disorders NEC Personality disorder Self esteem decreased Personality disorders with dramatic behaviour (Cluster B) Borderline personality disorder Psychiatric symptoms NEC Abulia Psychiatric symptom Psychotic disorder NEC Psychotic disorder Sexual arousal disorders Disturbance in sexual arousal Sexual desire disorders Libido decreased Sleep disorders NEC Hypersomnia-bulimia syndrome *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 39 of 51

40 Reaction Name Psychiatric disorders cont'd All Fatal All Fatal All Fatal Sleep disorder Speech articulation and rhythm disturbances Dysphemia Stereotypies and automatisms Bruxism Waxy flexibility Stress disorders Post-traumatic stress disorder Suicidal and self-injurious behaviour Suicidal ideation Suicide attempt Tic disorders Tic Psychiatric disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 40 of 51

41 Renal & urinary disorders Bladder and urethral symptoms Bladder irritation Bladder pain Dysuria Enuresis Incontinence Micturition disorder Pollakiuria Urethral pain Urinary incontinence Urinary retention Bladder disorders NEC Bladder disorder Glomerulonephritis and nephrotic syndrome Glomerulonephritis Glomerulonephritis acute Myoneurogenic bladder disorders Bladder dysfunction Nephritis NEC Tubulointerstitial nephritis Nephropathies and tubular disorders NEC Renal tubular acidosis Urinary abnormalities Chromaturia Haematuria Proteinuria Urine abnormality Urinary tract signs and symptoms NEC Cystitis-like symptom Nocturia Polyuria Renal pain Renal & urinary disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 41 of 51

42 Reproductive & breast disorders Breast disorders NEC Breast enlargement Breast mass Nipple disorder Breast signs and symptoms Breast discharge Breast discomfort Breast pain Breast swelling Breast tenderness Cervix disorders NEC Cervical dysplasia Menopausal effects NEC Premature menopause Menstruation and uterine bleeding NEC Dysmenorrhoea Menstrual disorder Menstruation irregular Metrorrhagia Premenstrual syndrome Menstruation with decreased bleeding Amenorrhoea Menstruation delayed Oligomenorrhoea Menstruation with increased bleeding Menometrorrhagia Menorrhagia Polymenorrhoea Ovarian and fallopian tube cysts and neoplasms Ovarian cyst Polycystic ovaries Ovarian and fallopian tube disorders NEC Ovulation pain Pelvis and broad ligament disorders NEC Adnexa uteri pain Reproductive tract signs and symptoms NEC Genital pain Oedema genital Pelvic pain Sexual function and fertility disorders NEC Dyspareunia *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 42 of 51

43 Reaction Name Reproductive & breast disorders cont'd All Fatal All Fatal All Fatal Infertility Infertility female Uterine disorders NEC Endometrial dysplasia Endometriosis Uterine pain Uterine neoplasms Uterine cyst Uterine tone disorders Uterine spasm Vulvovaginal disorders NEC Vaginal haemorrhage Vulval haemorrhage Vulvar dysplasia Vulvovaginal signs and symptoms Coital bleeding Vaginal discharge Vaginal odour Vaginismus Vulvovaginal discomfort Vulvovaginal dryness Vulvovaginal hypoaesthesia Vulvovaginal pain Vulvovaginal pruritus Reproductive & breast disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 43 of 51

44 Respiratory disorders Breathing abnormalities Dyspnoea Dyspnoea exertional Hyperventilation Hypopnoea Nocturnal dyspnoea Bronchospasm and obstruction Asthma Asthma exercise induced Bronchospasm Wheezing Coughing and associated symptoms Cough Haemoptysis Productive cough Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms) Laryngeal dyspnoea Vocal cord disorder Laryngeal spasm, oedema and obstruction Laryngeal oedema Lower respiratory tract inflammatory and immunologic conditions Lower respiratory tract inflammation Lower respiratory tract signs and symptoms Bronchial irritation Hiccups Pulmonary pain Nasal congestion and inflammations Nasal congestion Nasal inflammation Nasal disorders NEC Epistaxis Nasal disorder Nasal mucosal disorder Pharyngeal disorders (excl infections and neoplasms) Oropharyngeal spasm Pharyngeal erythema Pharyngeal oedema Tonsillar disorder Tonsillar hypertrophy Pleural infections and inflammations *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 44 of 51

45 Reaction Name Respiratory disorders cont'd All Fatal All Fatal All Fatal Pleurisy Pulmonary thrombotic and embolic conditions Pulmonary embolism Respiratory signs and symptoms NEC Diaphragmalgia Painful respiration Respiration abnormal Suffocation feeling Respiratory tract disorders NEC Lung disorder Pulmonary mass Respiratory tract irritation Tracheal disorders (excl infections and neoplasms) Tracheal disorder Upper respiratory tract signs and symptoms Chronic throat clearing Dry throat Dysphonia Oropharyngeal pain Rhinorrhoea Sneezing Throat irritation Throat tightness Respiratory disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 45 of 51

46 Skin disorders Acnes Acne Acne conglobata Dermatitis acneiform Alopecias Alopecia Alopecia areata Madarosis Angioedemas Angioedema Swelling face Apocrine and eccrine gland disorders Cold sweat Hyperhidrosis Night sweats Bullous conditions Blister Dermatitis bullous Erythema multiforme Pemphigus Stevens-Johnson syndrome Dermal and epidermal conditions NEC Dry skin Pain of skin Papule Scab Skin burning sensation Skin discolouration Skin disorder Skin reaction Skin swelling Skin tightness Skin warm Dermatitis and eczema Dermatitis Dermatitis allergic Dermatitis atopic Eczema Eczema asteatotic Eczema infantile Seborrhoeic dermatitis *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 46 of 51

47 Reaction Name Skin disorders cont'd All Fatal All Fatal All Fatal Skin irritation Erythemas Erythema Generalised erythema Plantar erythema Rash erythematous Exfoliative conditions Exfoliative rash Skin exfoliation Hyperkeratoses Keratosis pilaris Hyperpigmentation disorders Skin hyperpigmentation Solar lentigo Hypertrichoses Hypertrichosis Hypopigmentation disorders Skin depigmentation Skin hypopigmentation Nail and nail bed conditions (excl infections and infestations) Nail discolouration Nail disorder Nail growth abnormal Panniculitides Erythema nodosum Papulosquamous conditions Pityriasis rosea Rash papulosquamous Photosensitivity and photodermatosis conditions Photosensitivity reaction Solar dermatitis Pigmentation changes NEC Pigmentation disorder Pilar disorders NEC Hair disorder Hair growth abnormal Hair texture abnormal Pruritus NEC Pruritus Pruritus generalised Rash pruritic Psoriatic conditions *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 47 of 51

48 Reaction Name Skin disorders cont'd All Fatal All Fatal All Fatal Psoriasis Pustular psoriasis Purpura and related conditions Chronic pigmented purpura Ecchymosis Henoch-Schonlein purpura Petechiae Rashes, eruptions and exanthems NEC Rash Rash generalised Rash macular Rash maculo-papular Rash papular Rash vesicular Rosaceas Rosacea Skin and subcutaneous conditions NEC Skin mass Skin and subcutaneous tissue ulcerations Skin ulcer Skin dystrophies Skin wrinkling Skin haemorrhages Skin haemorrhage Skin hypoplasias and atrophies Skin atrophy Skin striae Skin vasculitides Hypersensitivity vasculitis Urticarias Mechanical urticaria Urticaria Urticaria chronic Urticaria contact Urticaria papular Urticaria thermal Skin disorders TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 48 of 51

49 Social circumstances Disability issues Activities of daily living impaired Bedridden Disability Impaired driving ability Impaired work ability Learning disability Mental disability Physical disability Sight disability Walking aid user Walking disability Wheelchair user Social issues NEC Social problem Social circumstances TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 49 of 51

50 Surgical & medical procedures Cardiac device therapeutic procedures Cardiac pacemaker insertion Cervix therapeutic procedures Cervical conisation Gastrointestinal therapeutic procedures NEC Gastrointestinal surgery Haematological therapeutic procedures NEC Bone marrow transplant Joint therapeutic procedures Ligament operation Large intestine therapeutic procedures Colostomy Limb therapeutic procedures Limb operation Lymphoid tissue therapeutic procedures Lymphadenectomy Splenectomy Thymectomy Nasal therapeutic procedures Nasal cavity packing Obstetric therapeutic procedures Caesarean section Small intestine therapeutic procedures Small intestine operation Therapeutic procedures NEC Infusion Tonsillar therapeutic procedures Adenoidectomy Tonsillectomy Surgical & medical procedures TOTAL *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 50 of 51

51 Vascular disorders Blood pressure disorders NEC Blood pressure fluctuation Labile blood pressure Circulatory collapse and shock Peripheral circulatory failure Shock Haemorrhages NEC Haematoma Haemorrhage Lymphoedemas Lymphoedema Non-site specific vascular disorders NEC Arterial disorder Hyperaemia Vascular pain Peripheral vascular disorders NEC Flushing Hot flush Peripheral vasoconstriction, necrosis and vascular insufficiency Peripheral coldness Raynaud's phenomenon Site specific vascular disorders NEC Pallor Vascular hypertensive disorders NEC Hypertension Vascular hypotensive disorders Hypotension Orthostatic hypotension Vasculitides NEC Granulomatosis with polyangiitis Polyarteritis nodosa Vasculitis Vascular disorders TOTAL TOTAL NUMBER OF REACTIONS TOTAL NUMBER OF FATAL ADR REPORTS* 0 2 2* TOTAL NUMBER OF ADR REPORTS* * *This provides the number of individual reports and may be less than the sum of the single-active and multi-active columns. For example, if both a single- and multi-active product are considered by the reporter to have a Page 51 of 51