Case Series Drug Analysis Print Name: Vaxigrip, Fluarix, Inflexal V og Influenzacvaccine 01Sep Oct2014

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Transcription:

- 16Oct2014 Report Run Date: 20-Oct-2014 Data Lock Date: 16-Oct-2014 19:00:06 Earliest Reaction Date: 28-Oct-2009 MedDRA Version: MedDRA 17.0 Vaxigrip, Fluarix, Inflexal V og Influenzacvaccine : Alle cases for Vaxigrip, Fluarix, Inflexal V og Influenzavaccination pr. og frem Report Run Date: 20-Oct-2014, Page 1

Blood disorders Lymphatic system disorders NEC Lymphadenopathy 1 0 Thrombocytopenias Thrombotic thrombocytopenic purpura 1 0 Blood disorders SOC TOTAL 2 0 Report Run Date: 20-Oct-2014, Page 2

Cardiac disorders Cardiac disorders NEC Cardiac disorder 1 0 Cardiac signs and symptoms NEC Palpitations 1 0 Ischaemic coronary artery disorders Angina pectoris 1 0 Noninfectious pericarditis Pericarditis 1 0 Cardiac disorders SOC TOTAL 4 0 Report Run Date: 20-Oct-2014, Page 3

Ear disorders Ear disorders NEC Ear swelling 1 0 Hearing losses Hearing impaired 1 0 Hyperacusia Hyperacusis 2 0 Inner ear signs and symptoms Tinnitus 3 0 Vertigo 1 0 Ear disorders SOC TOTAL 8 0 Report Run Date: 20-Oct-2014, Page 4

Eye disorders Lacrimation disorders Dry eye 1 0 Lid, lash and lacrimal infections, irritations and inflammations Eyelid oedema 1 0 Ocular disorders NEC Eye disorder 1 0 Eye swelling 1 0 Ocular infections, inflammations and associated manifestations Ocular hyperaemia 1 0 Ocular sensation disorders Photophobia 1 0 Visual disorders NEC Visual impairment 1 0 Eye disorders SOC TOTAL 7 0 Report Run Date: 20-Oct-2014, Page 5

Gastrointestinal disorders Gastrointestinal and abdominal pains (excl oral and throat) Abdominal pain 1 0 Abdominal pain upper 1 0 Nausea and vomiting symptoms Nausea 3 0 Vomiting 1 0 Oral soft tissue pain and paraesthesia Paraesthesia oral 1 0 Oral soft tissue signs and symptoms Burning mouth syndrome 1 0 Hypoaesthesia oral 1 0 Oral discomfort 1 0 Oral soft tissue swelling and oedema Lip swelling 1 0 Oedema mouth 1 0 Gastrointestinal disorders SOC TOTAL 12 0 Report Run Date: 20-Oct-2014, Page 6

General disorders Asthenic conditions Asthenia 2 0 Fatigue 8 0 Malaise 6 0 Death and sudden death Death 1 1 Febrile disorders Pyrexia 4 0 Feelings and sensations NEC Chills 1 0 Feeling abnormal 2 0 Feeling cold 1 0 General signs and symptoms NEC Influenza like illness 6 0 Local reaction 1 0 Local swelling 1 0 Injection site reactions Injection site erythema 4 0 Injection site joint movement impairment 1 0 Injection site pain 1 0 Injection site swelling 1 0 Oedema NEC Oedema 1 0 Oedema peripheral 1 0 Pain and discomfort NEC Discomfort 1 0 Pain 2 0 Tenderness 2 0 Vaccination site reactions Vaccination site pain 1 0 General disorders SOC TOTAL 48 1 Report Run Date: 20-Oct-2014, Page 7

Immune system disorders Allergic conditions NEC Hypersensitivity 2 0 Anaphylactic responses Anaphylactic reaction 1 0 Anaphylactic shock 1 0 Immune and associated conditions NEC Multiple chemical sensitivity 1 0 Immune system disorders SOC TOTAL 5 0 Report Run Date: 20-Oct-2014, Page 8

Infections Bacterial infections NEC Pneumonia bacterial 1 0 Herpes viral infections Herpes simplex 2 0 Influenza viral infections Influenza 1 0 Lower respiratory tract and lung infections Atypical pneumonia 1 0 Upper respiratory tract infections Pharyngitis 1 0 Viral infections NEC Post viral fatigue syndrome 1 0 Infections SOC TOTAL 7 0 Report Run Date: 20-Oct-2014, Page 9

Investigations Heart rate and pulse investigations Heart rate increased 1 0 Physical examination procedures and organ system status Weight decreased 1 0 Investigations SOC TOTAL 2 0 Report Run Date: 20-Oct-2014, Page 10

Metabolic disorders Food malabsorption and intolerance syndromes (excl sugar intolerance) Food intolerance 1 0 Metabolic disorders SOC TOTAL 1 0 Report Run Date: 20-Oct-2014, Page 11

Muscle & tissue disorders Arthropathies NEC Arthritis 1 0 Connective tissue disorders NEC Polymyalgia rheumatica 2 0 Joint related disorders NEC Periarthritis 1 0 Rotator cuff syndrome 1 0 Joint related signs and symptoms Arthralgia 7 0 Joint stiffness 1 0 Muscle pains Myalgia 5 0 Muscle related signs and symptoms NEC Muscle spasms 2 0 Musculoskeletal and connective tissue pain and discomfort Back pain 1 0 Musculoskeletal pain 2 0 Neck pain 1 0 Pain in extremity 2 0 Muscle & tissue disorders SOC TOTAL 26 0 Report Run Date: 20-Oct-2014, Page 12

Nervous system disorders Acute polyneuropathies Guillain-Barre syndrome 1 0 Polyneuropathy 1 0 Coordination and balance disturbances Balance disorder 2 0 Dyskinesias and movement disorders NEC Dyskinesia 1 0 Movement disorder 1 0 Facial cranial nerve disorders VIIth nerve paralysis 1 0 Headaches NEC Headache 5 0 Memory loss (excl dementia) Memory impairment 3 0 Mental impairment (excl dementia and memory loss) Cognitive disorder 1 0 Disturbance in attention 1 0 Migraine headaches Migraine 1 0 Mononeuropathies Peroneal nerve palsy 1 0 Narcolepsy and hypersomnia Hypersomnia 1 0 Neurological signs and symptoms NEC Dizziness 4 0 Presyncope 1 0 Paraesthesias and dysaesthesias Paraesthesia 4 0 Paralysis and paresis (excl cranial nerve) Paralysis 1 0 Sensory abnormalities NEC Dysgeusia 1 0 Neuralgia 2 0 Sensory disturbance 1 0 Tremor (excl congenital) Tremor 1 0 Nervous system disorders SOC TOTAL 35 0 Report Run Date: 20-Oct-2014, Page 13

Psychiatric disorders Disturbances in initiating and maintaining sleep Insomnia 1 0 Eating disorders NEC Eating disorder 1 0 Psychiatric disorders SOC TOTAL 2 0 Report Run Date: 20-Oct-2014, Page 14

Respiratory disorders Breathing abnormalities Dyspnoea 3 0 Upper respiratory tract signs and symptoms Dysphonia 1 0 Respiratory disorders SOC TOTAL 4 0 Report Run Date: 20-Oct-2014, Page 15

Skin disorders Angioedemas Angioedema 1 0 Swelling face 1 0 Apocrine and eccrine gland disorders Hyperhidrosis 2 0 Dermatitis and eczema Dermatitis 1 0 Erythemas Erythema 3 0 Rash erythematous 1 0 Pruritus NEC Pruritus 4 0 Purpura and related conditions Henoch-Schonlein purpura 1 0 Rashes, eruptions and exanthems NEC Rash 5 0 Skin hyperplasias and hypertrophies Skin hypertrophy 1 0 Urticarias Urticaria 4 0 Skin disorders SOC TOTAL 24 0 Report Run Date: 20-Oct-2014, Page 16

Social circumstances Disability issues Walking disability 1 0 Social circumstances SOC TOTAL 1 0 Report Run Date: 20-Oct-2014, Page 17

Vascular disorders Vascular hypertensive disorders NEC Hypertension 2 0 Vascular hypotensive disorders Orthostatic hypotension 1 0 Vascular disorders SOC TOTAL 3 0 TOTAL REACTIONS FOR DRUG 191 1 TOTAL REPORTS 46 TOTAL FATAL OUTCOME REPORTS 1 Report Run Date: 20-Oct-2014, Page 18

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