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FOI 19-459 Shingles Case Series Drug Analysis Print Name: FOI 19-459 Shingles DAP Report Run Date: 08-Oct-2019 Data Lock Date: 07-Oct-2019 19:00:04 Earliest Reaction Date: 09-Feb-2006 MedDRA Version: MedDRA 22.0 FOI 19-459 Shingles Shingles vaccine Drug Analysis Print. All UK DAP: spontaneous suspected shingles vaccine cases received up to and including the 7th October 2019. Report Run Date: 08-Oct-2019, Page 1 Case Series Drug Analysis Print Name: FOI 19-459 Shingles DAP Report Run Date: 08-Oct-2019 Data Lock Date: 07-Oct-2019 19:00:04 Earliest Reaction Date: 09-Feb-2006 MedDRA Version: MedDRA 22.0 Reaction Name Total Fatal Blood disorders Anaemias haemolytic immune Autoimmune haemolytic anaemia 1 0 Leukocytoses NEC Neutrophilia 1 0 Leukopenias NEC Lymphopenia 1 0 Lymphatic system disorders NEC Lymph node pain 2 0 Lymphadenopathy 9 0 Neutropenias Neutropenia 1 0 Thrombocytopenias Immune thrombocytopenic purpura 1 0 Thrombocytopenia 1 0 Blood disorders SOC TOTAL 17 0 Report Run Date: 08-Oct-2019, Page 2 Case Series Drug Analysis Print Name: FOI 19-459 Shingles DAP Report Run Date: 08-Oct-2019 Data Lock Date: 07-Oct-2019 19:00:04 Earliest Reaction Date: 09-Feb-2006 MedDRA Version: MedDRA 22.0 Reaction Name Total Fatal Cardiac disorders Cardiac signs and symptoms NEC Palpitations 8 0 Cardiomyopathies Cardiomyopathy 1 0 Coronary artery disorders NEC Arteriosclerosis coronary artery 1 0 Coronary artery disease 1 0 Heart failures NEC Cardiac failure 1 0 Ischaemic coronary artery disorders Acute myocardial infarction 1 1 Myocardial infarction 2 2 Rate and rhythm disorders NEC Arrhythmia 2 0 Tachycardia 3 0 Right ventricular failures Right ventricular failure 1 1 Supraventricular arrhythmias Atrial fibrillation 6 0 Cardiac disorders SOC TOTAL 27 4 Report Run Date: 08-Oct-2019, Page 3 Case Series Drug Analysis Print Name: FOI 19-459 Shingles DAP Report Run Date: 08-Oct-2019 Data Lock Date: 07-Oct-2019 19:00:04 Earliest Reaction Date: 09-Feb-2006 MedDRA Version: MedDRA 22.0 Reaction Name Total Fatal Ear disorders Ear disorders NEC Ear pain 8 0 Hearing disorders NEC Dysacusis 1 0 Hearing losses Deafness 1 0 Deafness neurosensory 2 0 Deafness unilateral 3 0 Hypoacusis 3 0 Inner ear disorders NEC Meniere's disease 1 0 Inner ear signs and symptoms Tinnitus 6 0 Vertigo 8 0 Vertigo positional 2 0 Ear disorders SOC TOTAL 35 0 Report Run Date: 08-Oct-2019, Page 4 Case Series Drug Analysis Print Name: FOI 19-459 Shingles DAP Report Run Date: 08-Oct-2019 Data Lock Date: 07-Oct-2019 19:00:04 Earliest Reaction Date: 09-Feb-2006 MedDRA Version: MedDRA 22.0 Reaction Name Total Fatal Endocrine disorders Acute and chronic thyroiditis Thyroiditis 1 0 Thyroid disorders NEC Goitre 1 0 Thyroid pain 1 0 Endocrine disorders SOC TOTAL 3 0 Report Run Date: 08-Oct-2019, Page 5 Case Series Drug Analysis Print Name: FOI 19-459 Shingles DAP Report Run Date: 08-Oct-2019 Data Lock Date: 07-Oct-2019 19:00:04 Earliest Reaction Date: 09-Feb-2006 MedDRA Version: MedDRA 22.0 Reaction Name Total Fatal Eye disorders Choroid and vitreous structural change, deposit and degeneration Vitreous floaters 3 0 Corneal structural change, deposit and degeneration Corneal lesion 1 0 Keratopathy 1 0 Eyelid movement disorders Eyelid ptosis 1 0 Glaucomas (excl congenital) Glaucoma 2 0 Iris and uveal tract infections, irritations and inflammations Iridocyclitis 2 0 Uveitis 4 0 Lacrimation disorders Dry eye 1 0 Lacrimation increased 2 0 Lid, lash and lacrimal infections, irritations and inflammations Eyelid irritation 1 0 Swelling of eyelid 3 0 Lid, lash and lacrimal structural disorders Dacryostenosis acquired 1 0 Ocular disorders NEC Eye disorder 2 0 Eye pain 9 0 Eye swelling 3 0 Periorbital oedema 2 0 Ocular infections, inflammations and associated manifestations Eye discharge 3 0 Eye inflammation 2 0 Eye irritation 2 0 Ocular nerve and muscle disorders Eye movement disorder 1 0 Ocular myasthenia 1 0 Ophthalmoplegia 1 0 Ocular sensation disorders Photophobia 4 0 Pupil disorders Mydriasis 1 0 Retinal structural change, deposit and degeneration Macular degeneration 1 0 Retinal, choroid and vitreous infections and inflammations Cystoid macular oedema 1 0 Necrotising retinitis 1 0 Visual disorders NEC Diplopia 3 0 Halo vision 1 0 Photopsia 2 0 Vision blurred 4 0 Visual impairment and blindness (excl colour blindness) Blindness 1 0 Blindness transient 1 0 Blindness unilateral 2 0 Visual acuity reduced 3 0 Visual impairment 6 0 Report Run Date: 08-Oct-2019, Page 6 Case Series Drug Analysis Print Name: FOI 19-459 Shingles DAP Report Run Date: 08-Oct-2019 Data Lock Date: 07-Oct-2019 19:00:04 Earliest Reaction Date: 09-Feb-2006 MedDRA Version: MedDRA 22.0 Reaction Name Total Fatal Eye disorders Eye disorders cont'd Eye disorders SOC TOTAL 79 0 Report Run Date: 08-Oct-2019, Page 7 Case Series Drug Analysis Print Name: FOI 19-459 Shingles DAP Report Run Date: 08-Oct-2019 Data Lock Date: 07-Oct-2019 19:00:04 Earliest Reaction Date: 09-Feb-2006 MedDRA Version: MedDRA 22.0 Reaction Name Total Fatal Gastrointestinal disorders Anal and rectal signs and symptoms Anal pruritus 1 0 Dental pain and sensation disorders Toothache 2 0 Diarrhoea (excl infective) Diarrhoea 21 0 Dyspeptic signs and symptoms Dyspepsia 3 0 Eructation 1 0 Faecal abnormalities NEC Faeces discoloured 1 0 Flatulence, bloating and distension Abdominal distension 1 0 Flatulence 1 0 Gastrointestinal and abdominal pains (excl oral and throat) Abdominal pain 9 0 Abdominal pain lower 1 0 Gastrointestinal atonic and hypomotility disorders NEC Constipation 2 0 Gastrointestinal disorders NEC Functional gastrointestinal disorder 1 0 Gastrointestinal dyskinetic disorders Change of bowel habit 1 0 Gastrointestinal signs and symptoms NEC Abdominal discomfort 9 0 Anal incontinence 1 0 Dysphagia 3 0 Gastrointestinal stenosis and obstruction NEC Intestinal obstruction 1 0 Gingival disorders, signs and symptoms NEC Gingival pain 2 0 Gingival swelling 1 0 Gingival ulceration 1 0 Nausea and vomiting symptoms Nausea 48 0 Retching 1 0 Vomiting 24 0 Non-site specific gastrointestinal haemorrhages Melaena 1 0 Oral dryness and saliva altered Dry mouth 2 0 Lip dry 1 0 Oral soft tissue disorders NEC Angina bullosa haemorrhagica 1 0 Chapped lips 1 0 Lip blister 2 0 Oral disorder 2 0 Oral lichen planus 1 0 Oral soft tissue pain and paraesthesia Oral pain 2 0 Paraesthesia oral 3 0 Oral soft tissue signs and symptoms Oral mucosal blistering 4 0 Report Run Date: 08-Oct-2019, Page 8 Case Series Drug Analysis Print Name: FOI 19-459 Shingles DAP Report Run Date: 08-Oct-2019 Data Lock Date: 07-Oct-2019 19:00:04 Earliest Reaction Date: 09-Feb-2006 MedDRA Version: MedDRA 22.0 Reaction Name Total Fatal Gastrointestinal disordersGastrointestinal disorders cont'd Oral soft tissue swelling and oedema Lip swelling 8 0 Mouth swelling 2 0 Salivary gland disorders NEC Salivary gland pain 1 0 Salivary gland enlargements Parotid gland enlargement 1 0 Stomatitis and ulceration Mouth ulceration 6 0 Stomatitis 1 0 Tongue signs and symptoms Glossodynia 4 0 Swollen tongue 3 0 Tongue blistering 1 0 Gastrointestinal disorders SOC TOTAL 183 0 Report Run Date: 08-Oct-2019, Page 9 Case Series Drug Analysis Print Name: FOI 19-459 Shingles DAP Report Run Date: 08-Oct-2019 Data Lock Date: 07-Oct-2019 19:00:04 Earliest Reaction Date: 09-Feb-2006 MedDRA Version: MedDRA 22.0 Reaction Name Total Fatal General disorders Application and instillation site reactions Application site erythema 1 0 Asthenic conditions Asthenia 25 0 Fatigue 40 0 Malaise 79 0 Death and sudden death Death 2 2 Sudden death 1 1 Febrile disorders Hyperpyrexia 1 0 Pyrexia 41 0 Feelings and sensations NEC Chills 20 0 Feeling abnormal 7 0 Feeling cold 6 0 Feeling hot 16 0 Feeling of body temperature change 5 0 Sensation of foreign body 1 0 Gait disturbances Gait disturbance 3 0 General signs and symptoms NEC Condition aggravated 11 0 Disease prodromal stage 1 0 Exercise tolerance decreased 1 0 General physical health deterioration 1 0 Induration 3 0 Influenza like illness 27 0 Local reaction 17 0 Multiple organ dysfunction syndrome 3 0 Peripheral swelling 35 0 Swelling 26 0 Inflammations Inflammation 9 0 Injection site reactions Injection site bruising 4 0 Injection site discolouration 1 0 Injection site discomfort 1 0 Injection site dryness 1 0 Injection site eczema 2 0 Injection site erosion 1 0 Injection site erythema 40 0 Injection site hypersensitivity 1 0 Injection site hypoaesthesia 1 0 Injection site induration 2 0 Injection site inflammation 2 0 Injection site irritation 1 0 Injection site mass 1 0 Injection site pain 19 0 Injection site paraesthesia 3 0 Injection site pruritus 16 0 Injection site rash 9 0 Injection site reaction 5 0 Report Run Date: 08-Oct-2019, Page 10 Case Series Drug Analysis Print Name: FOI 19-459 Shingles DAP Report Run Date: 08-Oct-2019 Data Lock Date: 07-Oct-2019 19:00:04 Earliest Reaction Date: 09-Feb-2006 MedDRA Version: MedDRA 22.0 Reaction Name Total Fatal General disorders General disorders cont'd Injection site scab 1 0 Injection site swelling 28 0 Injection site urticaria 1 0 Injection site vesicles 6 0 Injection site warmth 9 0 Oedema NEC Localised oedema 1 0 Oedema 1 0 Oedema peripheral 2 0 Pain and discomfort NEC Axillary pain 2 0 Chest discomfort 5 0 Chest pain 10 0 Discomfort 4 0 Facial pain 9 0 Pain 103 0 Tenderness 7 0 Therapeutic and nontherapeutic responses Drug ineffective 2 0 Therapeutic response unexpected 1 0 Therapy non-responder 1 0 Vaccination site reactions Vaccination site bruising 3 0 Vaccination site discomfort 2 0 Vaccination site dryness 1 0 Vaccination site erythema 26 0 Vaccination
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