Case Series Drug Analysis Print Name: DTPa IPV HIB
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1 Report Run Date: 20-Feb-2014 Data Lock Date: 18-Feb :01:22 Earliest Reaction Date: 02-Oct-2002 MedDRA Version: MedDRA 16.1 DTPa IPV HIB: Drug Analysis Print Report Run Date: 20-Feb-2014, Page 1
2 Blood disorders Lymphatic system disorders NEC Lymphadenopathy 1 0 Lymphoid tissue hyperplasia 1 0 Thrombocytopenias Idiopathic thrombocytopenic purpura 2 0 Thrombocytopenia 1 0 Blood disorders SOC TOTAL 5 0 Report Run Date: 20-Feb-2014, Page 2
3 Cardiac disorders Cardiac signs and symptoms NEC Cyanosis 41 0 Rate and rhythm disorders NEC Bradycardia 7 0 Tachycardia 5 0 Ventricular arrhythmias and cardiac arrest Cardiac arrest 3 1 Cardiac disorders SOC TOTAL 56 1 Report Run Date: 20-Feb-2014, Page 3
4 Congenital disorders Neurological disorders congenital NEC Congenital nystagmus 1 0 Persistent foetal circulation disorders Patent ductus arteriosus 1 0 Tongue disorders congenital Ankyloglossia congenital 1 0 Congenital disorders SOC TOTAL 3 0 Report Run Date: 20-Feb-2014, Page 4
5 Eye disorders Cataract conditions Cataract 1 0 Lacrimation disorders Lacrimation increased 1 0 Lid, lash and lacrimal infections, irritations and inflammations Eyelid oedema 1 0 Ocular disorders NEC Eye disorder 1 0 Eye swelling 2 0 Ocular infections, inflammations and associated manifestations Ocular hyperaemia 1 0 Ocular nerve and muscle disorders Eye movement disorder 9 0 Strabismus 1 0 Pupil disorders Mydriasis 1 0 Pupil fixed 1 0 Retinal bleeding and vascular disorders (excl retinopathy) Retinal haemorrhage 1 0 Visual disorders NEC Vision blurred 1 0 Visual impairment 4 0 Eye disorders SOC TOTAL 25 0 Report Run Date: 20-Feb-2014, Page 5
6 Gastrointestinal disorders Diarrhoea (excl infective) Diarrhoea 44 0 Diarrhoea haemorrhagic 1 0 Diarrhoea neonatal 1 0 Faecal abnormalities NEC Abnormal faeces 3 0 Faeces discoloured 2 0 Flatulence, bloating and distension Flatulence 1 0 Gastrointestinal and abdominal pains (excl oral and throat) Abdominal pain 3 0 Abdominal pain upper 2 0 Gastrointestinal pain 1 0 Infantile colic 2 0 Gastrointestinal atonic and hypomotility disorders NEC Constipation 3 0 Gastrooesophageal reflux disease 4 0 Gastrointestinal signs and symptoms NEC Abdominal discomfort 5 0 Gastrointestinal spastic and hypermotility disorders Frequent bowel movements 2 0 Nausea and vomiting symptoms Infantile spitting up 1 0 Nausea 1 0 Regurgitation 2 0 Retching 1 0 Vomiting 71 0 Vomiting neonatal 2 0 Vomiting projectile 3 0 Non-site specific gastrointestinal haemorrhages Haematochezia 2 0 Oral dryness and saliva altered Salivary hypersecretion 1 0 Oral soft tissue swelling and oedema Lip swelling 4 0 Salivary gland enlargements Parotid gland enlargement 1 0 Tongue signs and symptoms Protrusion tongue 1 0 Swollen tongue 6 0 Tongue oedema 1 0 Gastrointestinal disorders SOC TOTAL Report Run Date: 20-Feb-2014, Page 6
7 General disorders Adverse effect absent No adverse event 1 0 Asthenic conditions Fatigue 2 0 Malaise 30 0 Death and sudden death Death 2 2 Sudden infant death syndrome 4 4 Febrile disorders Hyperpyrexia 1 0 PFAPA syndrome 1 0 Pyrexia Feelings and sensations NEC Feeling abnormal 3 0 Feeling cold 2 0 Feeling hot 48 0 Feeling jittery 1 0 Gait disturbances Gait disturbance 3 0 General signs and symptoms NEC Condition aggravated 1 0 Crying Foaming at mouth 2 0 Glassy eyes 1 0 Induration 1 0 Irritability 54 0 Local reaction 69 0 Local swelling Secretion discharge 1 0 Swelling 40 0 Implant and catheter site reactions Implant site warmth 1 0 Inflammations Inflammation 35 0 Injection site reactions Injection site atrophy 1 0 Injection site bruising 5 0 Injection site discharge 1 0 Injection site discolouration 5 0 Injection site erythema Injection site granuloma 1 0 Injection site haemorrhage 1 0 Injection site induration 5 0 Injection site inflammation 21 0 Injection site irritation 2 0 Injection site mass 20 0 Injection site oedema 1 0 Injection site pain 18 0 Injection site pruritus 1 0 Injection site rash 7 0 Injection site reaction 43 0 Injection site swelling 96 0 Injection site urticaria 2 0 Report Run Date: 20-Feb-2014, Page 7
8 General disorders General disorders cont'd Injection site vesicles 3 0 Injection site warmth 17 0 Mass conditions NEC Mass 3 0 Oedema NEC Extensive swelling of vaccinated limb 1 0 Localised oedema 2 0 Oedema 2 0 Oedema peripheral 11 0 Pain and discomfort NEC Chest discomfort 1 0 Discomfort 6 0 Pain 18 0 Tenderness 5 0 Therapeutic and nontherapeutic responses Adverse reaction 1 0 Vaccination site reactions Vaccination site swelling 1 0 General disorders SOC TOTAL Report Run Date: 20-Feb-2014, Page 8
9 Immune system disorders Allergic conditions NEC Hypersensitivity 12 0 Serum sickness-like reaction 1 0 Type III immune complex mediated reaction 2 0 Allergies to foods, food additives, drugs and other chemicals Food allergy 1 0 Milk allergy 1 0 Anaphylactic responses Anaphylactic reaction 19 0 Anaphylactic shock 1 0 Anaphylactoid reaction 1 0 Autoimmune disorders NEC Autoimmune disorder 1 0 Immune and associated conditions NEC Immunisation reaction 5 0 Immune system disorders SOC TOTAL 44 0 Report Run Date: 20-Feb-2014, Page 9
10 Infections Abdominal and gastrointestinal infections Gastroenteritis 1 0 Bacterial infections NEC Arthritis bacterial 1 0 Cellulitis 22 0 Injection site cellulitis 1 0 Bordetella infections Pertussis 5 0 Central nervous system and spinal infections Meningitis 1 0 Haemophilus infections Haemophilus infection 1 1 Meningitis haemophilus 1 0 Pneumonia haemophilus 1 0 Herpes viral infections Eczema herpeticum 1 0 Oral herpes 1 0 Infections NEC Abscess 2 0 Injection site abscess 6 0 Injection site infection 4 0 Localised infection 1 0 Vaccination site abscess 2 0 Lower respiratory tract and lung infections Bronchopneumonia 4 1 Lobar pneumonia 1 0 Pneumonia 1 0 Neisseria infections Meningococcal infection 2 0 Meningococcal sepsis 1 0 Parainfluenzae viral infections Croup infectious 1 0 Salmonella infections Salmonellosis 1 0 Sepsis, bacteraemia, viraemia and fungaemia NEC Sepsis 4 0 Skin structures and soft tissue infections Eczema infected 2 0 Rash pustular 1 0 Skin infection 2 0 Streptococcal infections Pneumococcal infection 2 0 Pneumococcal sepsis 2 1 Upper respiratory tract infections Acute tonsillitis 1 0 Epiglottitis 2 0 Nasopharyngitis 2 0 Tracheitis 1 0 Upper respiratory tract infection 1 0 Urinary tract infections Urinary tract infection 2 0 Viral infections NEC Bronchiolitis 1 0 Report Run Date: 20-Feb-2014, Page 10
11 Infections Infections cont'd Kaposi's varicelliform eruption 1 0 Viral infection 3 0 Viral upper respiratory tract infection 1 0 Infections SOC TOTAL 90 3 Report Run Date: 20-Feb-2014, Page 11
12 Injuries Cerebral injuries NEC Subdural haemorrhage 2 0 Exposures associated with pregnancy, delivery and lactation Exposure during pregnancy 1 0 Foetal exposure during pregnancy 1 0 Maladministrations Drug administration error 1 0 Inappropriate schedule of drug administration 1 0 Incorrect dose administered 2 0 Wrong drug administered 5 0 Wrong technique in drug usage process 2 0 Medication errors NEC Medication error 1 0 Nerve injuries NEC Nerve injury 1 0 Non-site specific injuries NEC Wound secretion 1 0 Overdoses Accidental overdose 1 0 Overdose 3 0 Peripheral nerve injuries Injury to brachial plexus due to birth trauma 1 0 Skin injuries NEC Contusion 10 0 Vaccination related complications Vaccination complication 5 0 Vaccination failure 7 0 Injuries SOC TOTAL 45 0 Report Run Date: 20-Feb-2014, Page 12
13 Investigations Blood gas and acid base analyses Oxygen saturation decreased 6 0 Cerebrospinal fluid tests (excl microbiology) CSF white blood cell count increased 1 0 Coagulation and bleeding analyses Coagulation test abnormal 1 0 Heart rate and pulse investigations Heart rate decreased 1 0 Heart rate increased 3 0 Immunology analyses NEC Tryptase increased 1 0 Physical examination procedures and organ system status Body temperature increased 23 0 Respiratory rate decreased 1 0 Weight decreased 1 0 Platelet analyses Platelet count increased 2 0 Protein analyses NEC C-reactive protein increased 5 0 Renal function analyses Blood creatinine decreased 1 0 Blood urea decreased 1 0 Toxicology laboratory analyses Blood mercury abnormal 1 0 Urinalysis NEC Protein urine present 1 0 White blood cell analyses White blood cell count decreased 1 0 White blood cell count increased 2 0 Investigations SOC TOTAL 52 0 Report Run Date: 20-Feb-2014, Page 13
14 Metabolic disorders Appetite disorders Decreased appetite 19 0 Hypophagia 4 0 Increased appetite 1 0 Food malabsorption and intolerance syndromes (excl sugar intolerance) Cow's milk intolerance 1 0 General nutritional disorders NEC Failure to thrive 1 0 Feeding disorder 12 0 Feeding disorder neonatal 3 0 Feeding disorder of infancy or early childhood 12 0 Weight gain poor 3 0 Sugar intolerance (excl glucose intolerance) Lactose intolerance 1 0 Metabolic disorders SOC TOTAL 57 0 Report Run Date: 20-Feb-2014, Page 14
15 Muscle & tissue disorders Arthropathies NEC Polyarthritis 1 0 Joint related signs and symptoms Joint range of motion decreased 1 0 Joint swelling 6 0 Muscle related signs and symptoms NEC Muscle spasms 1 0 Muscle twitching 3 0 Muscle tone abnormalities Floppy infant 6 0 Muscle rigidity 9 0 Trismus 1 0 Muscle weakness conditions Muscular weakness 1 0 Musculoskeletal and connective tissue pain and discomfort Limb discomfort 1 0 Neck pain 1 0 Pain in extremity 15 0 Musculoskeletal and connective tissue signs and symptoms NEC Musculoskeletal stiffness 5 0 Weight bearing difficulty 1 0 Soft tissue disorders NEC Axillary mass 1 0 Muscle & tissue disorders SOC TOTAL 53 0 Report Run Date: 20-Feb-2014, Page 15
16 Nervous system disorders Abnormal reflexes Hyperreflexia 1 0 Absence seizures Petit mal epilepsy 1 0 Central nervous system haemorrhages and cerebrovascular accidents Intraventricular haemorrhage 1 0 Coordination and balance disturbances Nystagmus 2 0 Developmental disorders cognitive Autism 1 0 Disturbances in consciousness NEC Altered state of consciousness 1 0 Depressed level of consciousness 2 0 Lethargy 13 0 Loss of consciousness 10 0 Sedation 1 0 Somnolence 38 0 Syncope 12 0 Dyskinesias and movement disorders NEC Dyskinesia 8 0 Hypokinesia 2 0 Dystonias Dystonia 1 0 Encephalitis NEC Encephalitis 1 0 Generalised tonic-clonic seizures Grand mal convulsion 4 0 Headaches NEC Headache 1 0 Increased intracranial pressure disorders Brain oedema 1 0 Memory loss (excl dementia) Amnesia 1 0 Muscle tone abnormal Hypotonia 43 0 Narcolepsy and hypersomnia Hypersomnia 5 0 Neurological signs and symptoms NEC Dizziness 1 0 Fontanelle bulging 1 0 Grimacing 1 0 Myoclonus 1 0 Presyncope 4 0 Unresponsive to stimuli 26 0 Neuromuscular disorders NEC Hypotonic-hyporesponsive episode 9 0 Paraesthesias and dysaesthesias Hyperaesthesia 1 0 Seizures and seizure disorders NEC Convulsion 45 0 Epilepsy 2 0 Febrile convulsion 6 0 Infantile spasms 2 0 Report Run Date: 20-Feb-2014, Page 16
17 Nervous system disorders Nervous system disorders cont'd Myoclonic epilepsy 1 0 Partial seizures 4 0 Seizure cluster 1 0 Status epilepticus 1 0 Sensory abnormalities NEC Dysgeusia 1 0 Restless legs syndrome 1 0 Structural brain disorders NEC Brain injury 2 1 Tremor (excl congenital) Tremor 4 0 Nervous system disorders SOC TOTAL Report Run Date: 20-Feb-2014, Page 17
18 Pregnancy conditions Foetal complications NEC Foetal distress syndrome 1 0 Haemorrhagic complications of pregnancy Haemorrhage in pregnancy 1 0 Premature separation of placenta 1 0 Newborn complications NEC Neonatal disorder 3 0 Normal newborn status Normal newborn 1 0 Pregnancy conditions SOC TOTAL 7 0 Report Run Date: 20-Feb-2014, Page 18
19 Psychiatric disorders Abnormal behaviour NEC Abnormal behaviour 6 0 Breath holding 6 0 Staring 8 0 Anxiety symptoms Agitation 4 0 Agitation neonatal 2 0 Anxiety 1 0 Nervousness 1 0 Stress 1 0 Behaviour and socialisation disturbances Personality change 2 0 Confusion and disorientation Confusional state 1 0 Decreased physical activity levels Decreased activity 1 0 Disturbances in initiating and maintaining sleep Insomnia 1 0 Eating disorders NEC Eating disorder 3 0 Food aversion 1 0 Emotional and mood disturbances NEC Emotional distress 10 0 Mood altered 5 0 Fear symptoms and phobic disorders (incl social phobia) Fear 2 0 Increased physical activity levels Restlessness 9 0 Mood alterations with depressive symptoms Depressed mood 1 0 Mood disorders NEC Listless 5 0 Panic attacks and disorders Panic reaction 1 0 Perception disturbances Hallucination 1 0 Personality disorders with anxious behaviour (Cluster C) Dependent personality disorder 1 0 Psychiatric symptoms NEC Decreased eye contact 2 0 Sleep disorders NEC Sleep disorder 8 0 Speech articulation and rhythm disturbances Screaming 63 0 Tic disorders Tic 1 0 Psychiatric disorders SOC TOTAL Report Run Date: 20-Feb-2014, Page 19
20 Renal & urinary disorders Bladder and urethral symptoms Dysuria 1 0 Enuresis 1 0 Micturition urgency 1 0 Urinary incontinence 1 0 Glomerulonephritis and nephrotic syndrome Nephrotic syndrome 1 0 Renal & urinary disorders SOC TOTAL 5 0 Report Run Date: 20-Feb-2014, Page 20
21 Respiratory disorders Breathing abnormalities Apnoea 11 0 Apnoeic attack 3 0 Dyspnoea 17 0 Grunting 2 0 Hypopnoea 5 0 Respiratory arrest 12 1 Respiratory distress 2 0 Tachypnoea 1 0 Bronchospasm and obstruction Wheezing 11 0 Conditions associated with abnormal gas exchange Hypoxia 1 1 Coughing and associated symptoms Cough 11 0 Productive cough 1 0 Laryngeal spasm, oedema and obstruction Stridor 1 0 Nasal congestion and inflammations Nasal congestion 1 0 Neonatal hypoxic conditions Apnoea neonatal 2 0 Newborn respiratory disorders NEC Respiratory disorder neonatal 1 0 Paranasal sinus disorders (excl infections and neoplasms) Sinus congestion 1 0 Pharyngeal disorders (excl infections and neoplasms) Pharyngeal erythema 1 0 Respiratory tract disorders NEC Lung disorder 1 1 Respiratory disorder 6 0 Tracheal disorders (excl infections and neoplasms) Tracheal disorder 1 0 Upper respiratory tract signs and symptoms Choking 2 0 Dysphonia 2 0 Increased upper airway secretion 1 0 Rhinorrhoea 3 0 Sneezing 1 0 Yawning 1 0 Respiratory disorders SOC TOTAL Report Run Date: 20-Feb-2014, Page 21
22 Skin disorders Angioedemas Angioedema 3 0 Swelling face 10 0 Apocrine and eccrine gland disorders Cold sweat 6 0 Hyperhidrosis 6 0 Bullous conditions Blister 15 0 Blood blister 2 0 Erythema multiforme 4 0 Pemphigoid 3 0 Dermal and epidermal conditions NEC Dry skin 6 0 Macule 1 0 Pain of skin 2 0 Scab 2 0 Skin burning sensation 1 0 Skin discolouration 18 0 Skin discomfort 1 0 Skin disorder 3 0 Skin induration 1 0 Skin lesion 3 0 Skin odour abnormal 1 0 Skin reaction 18 0 Skin sensitisation 1 0 Skin tightness 2 0 Skin warm 9 0 Yellow skin 1 0 Dermatitis and eczema Dermatitis allergic 5 0 Dermatitis atopic 1 0 Dermatitis diaper 2 0 Eczema 8 0 Eczema infantile 1 0 Skin irritation 1 0 Erythemas Erythema Generalised erythema 6 0 Rash erythematous 16 0 Exfoliative conditions Skin exfoliation 2 0 Papulosquamous conditions Rash papular 5 0 Pigmentation changes NEC Post inflammatory pigmentation change 1 0 Pruritus NEC Pruritus 9 0 Pruritus generalised 1 0 Rash pruritic 3 0 Purpura and related conditions Petechiae 37 0 Purpura 18 0 Rashes, eruptions and exanthems NEC Report Run Date: 20-Feb-2014, Page 22
23 Skin disorders Skin disorders cont'd Rash 81 0 Rash generalised 37 0 Rash macular 48 0 Rash maculo-papular 12 0 Rash vesicular 1 0 Skin dystrophies Hypertrophic scar 1 0 Skin haemorrhages Skin haemorrhage 1 0 Skin vasculitides Vasculitic rash 3 0 Skin vasomotor conditions Livedo reticularis 7 0 Urticarias Urticaria 42 0 Urticaria pigmentosa 1 0 Skin disorders SOC TOTAL Report Run Date: 20-Feb-2014, Page 23
24 Social circumstances Disability issues Immobile 2 0 Social circumstances SOC TOTAL 2 0 Report Run Date: 20-Feb-2014, Page 24
25 Surgical & medical procedures Obstetric therapeutic procedures Vacuum extractor delivery 1 0 Surgical & medical procedures SOC TOTAL 1 0 Report Run Date: 20-Feb-2014, Page 25
26 Vascular disorders Circulatory collapse and shock Circulatory collapse 2 0 Shock 6 0 Haemorrhages NEC Haematoma 1 0 Haemorrhage 1 0 Non-site specific vascular disorders NEC Capillary fragility 1 0 Hyperaemia 1 0 Peripheral vascular disorders NEC Flushing 8 0 Hot flush 2 0 Peripheral vasoconstriction, necrosis and vascular insufficiency Peripheral coldness 2 0 Site specific vascular disorders NEC Pallor 83 0 Vascular hypotensive disorders Hypotension 1 0 Vascular disorders SOC TOTAL TOTAL REACTIONS FOR DRUG TOTAL REPORTS 1265 TOTAL FATAL OUTCOME REPORTS 14 Report Run Date: 20-Feb-2014, Page 26
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