Case Series Drug Analysis Print. MFR (minus studies):
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1 Report Run Date: 25-Feb-2015 Data Lock Date: 23-Feb :00:10 Earliest Reaction Date: 01-Oct-2005 MedDRA Version: MedDRA 17.1 MFR (minus studies): M-M-RVAXPRO, MMR, MÆSLINGER OG FÅRESYGE OG RØDE HUNDE, PRIORIX Report Run Date: 25-Feb-2015, Page 1
2 Blood disorders Leukopenias NEC Leukopenia 1 0 Lymphatic system disorders NEC Lymphadenopathy 5 0 Neutropenias Neutropenia 1 0 Thrombocytopenias Immune thrombocytopenic purpura 4 0 Thrombocytopenia 1 0 Thrombocytoses Thrombocytosis 1 0 Blood disorders SOC TOTAL 13 0 Report Run Date: 25-Feb-2015, Page 2
3 Cardiac disorders Ischaemic coronary artery disorders Angina pectoris 1 0 Rate and rhythm disorders NEC Arrhythmia 1 0 Bradycardia 1 0 Cardiac disorders SOC TOTAL 3 0 Report Run Date: 25-Feb-2015, Page 3
4 Congenital disorders Central nervous system disorders congenital NEC Syringomyelia 1 0 Congenital disorders SOC TOTAL 1 0 Report Run Date: 25-Feb-2015, Page 4
5 Ear disorders Ear disorders NEC Ear pain 1 0 Ear pruritus 1 0 Hearing losses Deafness 1 0 Hearing impaired 2 0 Inner ear signs and symptoms Tinnitus 2 0 Ear disorders SOC TOTAL 7 0 Report Run Date: 25-Feb-2015, Page 5
6 Endocrine disorders Acute and chronic thyroiditis Autoimmune thyroiditis 1 0 Thyroid hyperfunction disorders Hyperthyroidism 1 0 Endocrine disorders SOC TOTAL 2 0 Report Run Date: 25-Feb-2015, Page 6
7 Eye disorders Ocular disorders NEC Eye swelling 2 0 Ocular infections, inflammations and associated manifestations Ocular hyperaemia 2 0 Visual disorders NEC Diplopia 1 0 Photopsia 1 0 Vision blurred 3 0 Visual impairment 3 0 Eye disorders SOC TOTAL 12 0 Report Run Date: 25-Feb-2015, Page 7
8 Gastrointestinal disorders Diarrhoea (excl infective) Diarrhoea 3 0 Gastrointestinal and abdominal pains (excl oral and throat) Abdominal pain upper 1 0 Gastrointestinal atonic and hypomotility disorders NEC Constipation 1 0 Gastrointestinal signs and symptoms NEC Dysphagia 1 0 Gingival haemorrhages Gingival bleeding 1 0 Malabsorption syndromes Coeliac disease 1 0 Nausea and vomiting symptoms Nausea 5 0 Vomiting 5 0 Oral soft tissue haemorrhages Mouth haemorrhage 1 0 Salivary gland enlargements Parotid gland enlargement 1 0 Gastrointestinal disorders SOC TOTAL 20 0 Report Run Date: 25-Feb-2015, Page 8
9 General disorders Asthenic conditions Asthenia 3 0 Fatigue 11 0 Malaise 4 0 Febrile disorders Pyrexia 62 0 Feelings and sensations NEC Chills 1 0 Gait disturbances Gait disturbance 8 0 General signs and symptoms NEC Crying 1 0 General physical health deterioration 2 0 Influenza like illness 4 0 Local reaction 1 0 Swelling 2 0 Healing abnormal NEC Impaired healing 1 0 Injection site reactions Injection site eczema 4 0 Injection site erosion 1 0 Injection site erythema 4 0 Injection site extravasation 2 0 Injection site granuloma 4 0 Injection site nodule 1 0 Injection site pain 8 0 Injection site papule 1 0 Injection site pruritus 8 0 Injection site rash 3 0 Injection site swelling 4 0 Mass conditions NEC Nodule 2 0 Pain and discomfort NEC Chest pain 1 0 Discomfort 1 0 Pain 4 0 Vaccination site reactions Vaccination site discolouration 2 0 Vaccination site granuloma 9 0 Vaccination site irritation 1 0 Vaccination site nodule 1 0 Vaccination site pain 2 0 Vaccination site pruritus 4 0 Vaccination site rash 1 0 General disorders SOC TOTAL Report Run Date: 25-Feb-2015, Page 9
10 Immune system disorders Allergic conditions NEC Allergy to metals 5 0 Hypersensitivity 2 0 Allergies to foods, food additives, drugs and other chemicals Reaction to drug excipients 8 0 Anaphylactic responses Anaphylactic reaction 1 0 Immune system disorders SOC TOTAL 16 0 Report Run Date: 25-Feb-2015, Page 10
11 Infections Bacterial infections NEC Tonsillitis bacterial 1 0 Candida infections Oral candidiasis 1 0 Dental and oral soft tissue infections Parotitis 3 0 Eye and eyelid infections Conjunctivitis 2 0 Herpes viral infections Herpes zoster 1 0 Male reproductive tract infections Orchitis 1 0 Mumps viral infections Mumps 1 0 Mycoplasma infections Mycoplasma infection 1 0 Rubella viral infections Rubella 2 0 Rubeola viral infections Measles 3 0 Measles post vaccine 1 0 Upper respiratory tract infections Nasopharyngitis 4 0 Rhinitis 2 0 Tonsillitis 1 0 Viral infections NEC Viral rash 1 0 Infections SOC TOTAL 25 0 Report Run Date: 25-Feb-2015, Page 11
12 Injuries Cerebral injuries NEC Concussion 1 0 Maladministrations Incorrect route of drug administration 1 0 Non-site specific injuries NEC Fall 3 0 Skin injuries NEC Contusion 2 0 Vaccination related complications Vaccination failure 1 0 Injuries SOC TOTAL 8 0 Report Run Date: 25-Feb-2015, Page 12
13 Investigations Cerebrospinal fluid tests (excl microbiology) CSF cell count abnormal 1 0 Coagulation and bleeding analyses Coagulation factor increased 1 0 Investigations NEC Quality of life decreased 1 0 Physical examination procedures and organ system status Weight decreased 1 0 Weight increased 1 0 Platelet analyses Platelet count decreased 2 0 Urinalysis NEC Protein urine 1 0 Vascular tests NEC (incl blood pressure) Blood pressure decreased 1 0 Virus identification and serology Morbillivirus test positive 1 0 Investigations SOC TOTAL 10 0 Report Run Date: 25-Feb-2015, Page 13
14 Metabolic disorders Appetite disorders Decreased appetite 5 0 Diabetes mellitus (incl subtypes) Diabetes mellitus 1 0 Food malabsorption and intolerance syndromes (excl sugar intolerance) Food intolerance 1 0 Total fluid volume decreased Dehydration 1 0 Metabolic disorders SOC TOTAL 8 0 Report Run Date: 25-Feb-2015, Page 14
15 Muscle & tissue disorders Arthropathies NEC Arthritis reactive 3 0 Arthropathy 1 0 Bone related signs and symptoms Bone pain 1 0 Connective tissue disorders NEC Connective tissue disorder 1 0 Joint related signs and symptoms Arthralgia 5 0 Joint swelling 1 0 Lupus erythematosus (incl subtypes) Systemic lupus erythematosus 1 0 Muscle pains Myalgia 3 0 Muscle weakness conditions Muscular weakness 2 0 Musculoskeletal and connective tissue pain and discomfort Back pain 1 0 Musculoskeletal pain 2 0 Neck pain 5 0 Pain in extremity 4 0 Musculoskeletal and connective tissue signs and symptoms NEC Growth retardation 1 0 Rheumatoid arthropathies Rheumatoid arthritis 1 0 Spine and neck deformities Scoliosis 1 0 Synovial disorders Synovitis 1 0 Muscle & tissue disorders SOC TOTAL 34 0 Report Run Date: 25-Feb-2015, Page 15
16 Nervous system disorders Absence seizures Petit mal epilepsy 1 0 Acute polyneuropathies Guillain-Barre syndrome 3 0 Polyneuropathy 1 0 Autonomic nervous system disorders Autonomic nervous system imbalance 1 0 Coordination and balance disturbances Ataxia 1 0 Balance disorder 4 0 Coordination abnormal 1 0 Cortical dysfunction NEC Aphasia 1 0 Demyelinating disorders NEC Acute disseminated encephalomyelitis 1 0 Demyelination 1 0 Developmental disorders cognitive Autism 3 0 Disturbances in consciousness NEC Altered state of consciousness 1 0 Syncope 4 0 Dyskinesias and movement disorders NEC Dyskinesia 1 0 Hypokinesia 1 0 Dystonias Opisthotonus 1 0 Encephalitis NEC Encephalitis post immunisation 1 0 Facial cranial nerve disorders Facial paresis 3 0 Generalised tonic-clonic seizures Generalised tonic-clonic seizure 1 0 Headaches NEC Headache 10 0 Memory loss (excl dementia) Amnesia 1 0 Mental impairment (excl dementia and memory loss) Disturbance in attention 1 0 Motor neurone diseases Motor neurone disease 1 0 Narcolepsy and hypersomnia Hypersomnia 1 0 Nervous system disorders NEC Motor dysfunction 2 0 Neurological signs and symptoms NEC Dizziness 5 0 Drooling 1 0 Presyncope 3 0 Optic nerve disorders NEC Optic neuritis 1 0 Paraesthesias and dysaesthesias Burning sensation 1 0 Hypoaesthesia 1 0 Report Run Date: 25-Feb-2015, Page 16
17 Nervous system disorders Nervous system disorders cont'd Paraesthesia 1 0 Paralysis and paresis (excl cranial nerve) Paralysis 1 0 Paresis 1 0 Seizures and seizure disorders NEC Convulsion 4 0 Epilepsy 2 0 Febrile convulsion 6 0 Status epilepticus 2 0 Speech and language abnormalities Dyslalia 1 0 Speech disorder 1 0 Speech disorder developmental 1 0 Nervous system disorders SOC TOTAL 79 0 Report Run Date: 25-Feb-2015, Page 17
18 Psychiatric disorders Behaviour and socialisation disturbances Social avoidant behaviour 1 0 Confusion and disorientation Confusional state 2 0 Dissociative states Dissociation 1 0 Disturbances in initiating and maintaining sleep Insomnia 2 0 Emotional and mood disturbances NEC Irritability 1 0 Fluctuating mood symptoms Mood swings 1 0 Personality disorders NEC Personality disorder 1 0 Pervasive developmental disorders NEC Autism spectrum disorder 1 0 Psychotic disorder NEC Psychotic disorder 1 0 Sleep disorders NEC Sleep disorder 1 0 Psychiatric disorders SOC TOTAL 12 0 Report Run Date: 25-Feb-2015, Page 18
19 Renal & urinary disorders Bladder and urethral symptoms Urinary retention 1 0 Renal & urinary disorders SOC TOTAL 1 0 Report Run Date: 25-Feb-2015, Page 19
20 Reproductive & breast disorders Testicular and epididymal disorders NEC Testicular pain 1 0 Testicular swelling 1 0 Reproductive & breast disorders SOC TOTAL 2 0 Report Run Date: 25-Feb-2015, Page 20
21 Respiratory disorders Breathing abnormalities Dyspnoea 1 0 Bronchospasm and obstruction Asthma 1 0 Coughing and associated symptoms Cough 2 0 Productive cough 1 0 Pharyngeal disorders (excl infections and neoplasms) Pharyngeal erythema 2 0 Tonsillar hypertrophy 1 0 Upper respiratory tract signs and symptoms Catarrh 3 0 Increased viscosity of nasal secretion 1 0 Oropharyngeal pain 2 0 Respiratory disorders SOC TOTAL 14 0 Report Run Date: 25-Feb-2015, Page 21
22 Skin disorders Alopecias Alopecia 1 0 Apocrine and eccrine gland disorders Hyperhidrosis 1 0 Bullous conditions Blister 1 0 Dermal and epidermal conditions NEC Skin induration 1 0 Dermatitis and eczema Dermatitis 1 0 Dermatitis atopic 1 0 Eczema 3 0 Eczema asteatotic 1 0 Dermatitis ascribed to specific agent Drug eruption 1 0 Erythemas Erythema 5 0 Rash erythematous 5 0 Nail and nail bed conditions (excl infections and infestations) Nail disorder 1 0 Papulosquamous conditions Rash papular 1 0 Photosensitivity and photodermatosis conditions Photosensitivity reaction 1 0 Pilar disorders NEC Hair growth abnormal 4 0 Pruritus NEC Pruritus 12 0 Rash pruritic 5 0 Purpura and related conditions Henoch-Schonlein purpura 1 0 Petechiae 3 0 Rashes, eruptions and exanthems NEC Rash 14 0 Rash generalised 3 0 Rash macular 2 0 Rash maculo-papular 2 0 Rash morbilliform 14 0 Skin and subcutaneous conditions NEC Excessive granulation tissue 2 0 Skin mass 3 0 Skin cysts and polyps Dermal cyst 1 0 Urticarias Cold urticaria 1 0 Urticaria 9 0 Skin disorders SOC TOTAL Report Run Date: 25-Feb-2015, Page 22
23 Social circumstances Disability issues Disability 1 0 Social circumstances SOC TOTAL 1 0 Report Run Date: 25-Feb-2015, Page 23
24 Surgical & medical procedures Inner ear therapeutic procedures Cochlea implant 1 0 Surgical & medical procedures SOC TOTAL 1 0 Report Run Date: 25-Feb-2015, Page 24
25 Vascular disorders Peripheral vascular disorders NEC Hot flush 1 0 Peripheral vasoconstriction, necrosis and vascular insufficiency Peripheral coldness 1 0 Raynaud's phenomenon 1 0 Vascular disorders SOC TOTAL 3 0 TOTAL REACTIONS FOR DRUG TOTAL REPORTS 173 Report Run Date: 25-Feb-2015, Page 25
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