Summary listing of suspected adverse reactions and events associated with use of Gardasil 01/06/ /12/2015

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1 Injection site swelling Transient immobility Abdominal pain Visual acuity reduced Chronic fatigue syndrome Mental disorder Pallor Dyskinesia Pharyngitis streptococcal Gait disturbance Psychiatric symptom Vision blurred Aphonia Musculoskeletal stiffness Paralysis Insomnia Gait disturbance Feeling cold Helicobacter infection Gastrointestinal inflammation Gastrooesophageal reflux disease Heart rate increased Blood glucose decreased Activities of daily living impaired Abdominal pain Post viral fatigue syndrome Fibromyalgia Ovarian cyst Eye disorder Hyperacusis Food intolerance Transient memory impairment Post viral fatigue syndrome Chronic fatigue syndrome

2 Visual impairment Eye movement disorder Abdominal pain upper Skin discolouration Aphasia Joint swelling Dyskinesia Facial pain Eye pain in extremity MENJUGATE MENJUGATE Injection site swelling Cataplexy Chronic fatigue syndrome Abdominal pain Menstrual disorder Mood swings Photosensitivity reaction Ovarian cyst Depressed mood Musculoskeletal pain Alopecia Erythema Neuralgia Joint swelling Quality of life decreased Limb discomfort Abdominal pain upper Depressed mood Paraesthesia Injection site erythema Injection site swelling

3 Musculoskeletal stiffness Hallucination Pallor Cold sweat Pallor Cold sweat Pallor Feeling cold Cold sweat Generalised tonic-clonic seizure Somnolence Gastrooesophageal reflux disease Irritable bowel syndrome Vision blurred Blood iron decreased Menorrhagia Tremor Diarrhoea Constipation Feeling cold in extremity Poor quality sleep Chapped lips Dry skin Somnolence Menstruation irregular Vulvovaginal pain Vaginal discharge Urinary tract infection Weight increased Thirst

4 Chronic fatigue syndrome Insomnia Cognitive disorder Amnesia Obsessive-compulsive disorder Menorrhagia Asthma Weight decreased Immune system disorder Chills Muscle atrophy Activities of daily living impaired Influenza like illness Pneumonia Home care Visual impairment Gastrooesophageal reflux disease Pulse abnormal Tremor Visual impairment Poor quality sleep Body temperature fluctuation Skin sensitisation Joint stiffness Mobility decreased Gastrointestinal disorder Fibromyalgia Irritable bowel syndrome Developmental hip dysplasia Stress Hyperkeratosis Immunodeficiency Back pain Erythema Inflammation

5 Vision blurred Neck pain Contusion Photophobia Lethargy Meningitis viral Orthostatic hypotension Sinusitis Nasal polyps Diarrhoea Decreased appetite Sleep terror Heart rate irregular Irritable bowel syndrome Constipation Epstein-Barr virus antibody positive Pancreatitis acute Appendicitis Hot flush Trismus Epistaxis Eating disorder Coordination abnormal in extremity Social avoidant behaviour Pallor Balance disorder Abdominal pain upper Lethargy Balance disorder Activities of daily living impaired Back pain Neck pain Vitamin D deficiency Skin striae Tremor Volume blood decreased Altered visual depth perception

6 Vision blurred in extremity Back pain Nightmare Diplopia Amnesia Confusional state Lymphadenopathy Cyanosis Diarrhoea Complex regional pain syndrome DIPHTHERIA/TETANUS/P ERTUSSIS VACCINE Sensory loss Food intolerance Amnesia Abdominal pain Sleep disorder Menstrual disorder Visual impairment transient Hypertension Cold sweat Tremor Injection site pain in extremity Photophobia

7 Insomnia in extremity Diarrhoea Influenza like illness Vision blurred Epistaxis Dysmenorrhoea Hormone level abnormal Fibromyalgia Peripheral coldness Skin striae Varicose vein Oral fungal infection Breath odour Hyperhidrosis Flushing Glassy eyes Lacrimation increased Post viral fatigue syndrome Photophobia Irlen syndrome Back pain Amnesia Autoimmune disorder Connective tissue disorder Joint swelling Alopecia Mouth ulceration Gait disturbance Depressed mood Neurological symptom Paraesthesia Visual impairment Epilepsy

8 Postural orthostatic tachycardia syndrome Abdominal discomfort Swelling Swelling face Peripheral swelling Allodynia Amenorrhoea Pneumonia aspiration Hypersomnia Dysmenorrhoea Fibromyalgia Postural orthostatic tachycardia syndrome Transient memory impairment Mental impairment Photophobia Hyperacusis Menstrual disorder Feeling cold Postural orthostatic tachycardia syndrome Nasopharyngitis Abdominal migraine Sleep disorder Ear pain Blepharitis Tremor Body temperature fluctuation Skin discolouration Abdominal distension Menstruation irregular Tachycardia in extremity Dyskinesia Blepharospasm Loss of consciousness Sleep disorder Nightmare Feeling cold

9 DF 1 DF Influenza like illness Lip swelling Eye swelling Pruritus Peripheral swelling Injection site swelling Gastric disorder Functional gastrointestinal disorder Gastrointestinal disorder in extremity Fall Bite Loss of consciousness Visual impairment in extremity Reflux gastritis Sensory disturbance Cognitive disorder Hypersomnia Gastrointestinal disorder Menstrual disorder Dysmenorrhoea Diarrhoea Thirst Paraesthesia Drop attacks Dyskinesia Visual acuity reduced Vision blurred Eye pain

10 Vein rupture Ovarian cyst Nightmare Fall in extremity Peripheral coldness Musculoskeletal stiffness Muscle rigidity Haematochezia Insomnia Heart rate increased Dysstasia Presyncope Tremor papular Bedridden Feeling of body temperature change Loss of consciousness Abdominal pain in extremity Complex regional pain syndrome Peripheral swelling Neck pain Insomnia Autoimmune disorder Hormone level abnormal Fibromyalgia Postural orthostatic tachycardia syndrome Memory impairment Menstrual disorder Psychiatric symptom Cardiac disorder

11 11 Epilepsy

12 Heart rate irregular Disability Personality change Trismus Pancreatitis Menorrhagia Endometriosis Raynaud's phenomenon Fibromyalgia Systemic lupus erythematosus ml 5 ml 5 ml Decreased appetite Abdominal pain like phenomena Irritable bowel syndrome Postural orthostatic tachycardia syndrome Contusion Immune thrombocytopenic purpura Limb discomfort Influenza like illness Nasopharyngitis Lichen sclerosus Dysuria ful defaecation Tonsillitis

13 Back pain Abdominal pain upper Lethargy Sleep disorder Gluten sensitivity Irritable bowel syndrome Menstruation irregular Dysmenorrhoea

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