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This is VAERS ID 649341

Case Details

VAERS ID: 649341 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
   Days after vaccination:0
Submitted: 2016-08-24
   Days after onset:1800
Entered: 2016-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abdominal tenderness, Alopecia, Anxiety, Aphasia, Arthralgia, Back pain, Breast pain, Candida infection, Chest pain, Cough, Dermatitis, Diarrhoea, Discomfort, Disturbance in attention, Dizziness, Dyskinesia, Ear pain, Epigastric discomfort, Eye discharge, Eye pain, Fatigue, Feeling abnormal, Formication, Gait disturbance, Gastritis, Headache, Heart rate increased, Heart rate irregular, Hyperacusis, Hypoaesthesia, Impaired healing, Increased tendency to bruise, Influenza like illness, Injection site erythema, Injection site swelling, Insomnia, Irritability, Lip infection, Lip injury, Lip swelling, Lymphadenopathy, Menorrhagia, Menstruation irregular, Mood swings, Muscle spasms, Muscle twitching, Nausea, Oral mucosal blistering, Oropharyngeal pain, Pain in extremity, Pain in jaw, Pharyngeal oedema, Photophobia, Polycystic ovaries, Pruritus, Rash, Seizure, Syncope, Temperature intolerance, Toothache, Urticaria, Weight fluctuation, Wound haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal infections (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Lipodystrophy (broad), Osteonecrosis (broad), Fertility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1608IRL011237

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number IE-1577272925-2016008324) on 22-AUG-2016. This case was received from the agency on 17-08-2016 under the reference number IE-HPRA-2016-027459 Initial report was received by the agency on 02-AUG-2016 from a member of the public (MOP) (patient''s mother) which concerns a 13 year-old female patient who experienced injection site swelling, headache, fatigue, influenza like illness, cough, oropharyngeal pain, Epigastric discomfort, eye discharge, lymphadenopathy, ear pain, chest pain, abdominal pain, arthralgia, gastritis, diarrhea, abdominal tenderness, menorrhagia, mood swings, disturbance in attention, urticarial, eye pain, syncope, back pain, dizziness, nausea, feeling abnormal, alopecia, polycystic ovaries, menstruation irregular, muscle spasms, hypoaesthesia, pruritus, rash, increased tendency to bruise, wound haemorrhage, impaired healing, lip swelling, lip injury, oral mucosal blistering, insomnia, muscle twitching, aphasia, hyperacusis, photophobia, anxiety, temperature intolerance, irritability, pain in jaw, toothache, weight fluctuation, Candida infection, pain in extremity, seizure, breast pain, heart rate increased, heart rate irregular, formication, lip infection, dyskinesia, arthralgia, pharyngeal oedema, injection site erythema, dermatitis, discomfort and gait disturbance following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: None. The reporter indicated that the patient was perfectly healthy prior to GARDASIL vaccinations. The patient was vaccinated with three doses of GARDASIL - dose 1 on 20-SEP-2011 (batch/lot no. NN40800), dose 2 on 22-NOV-2011 (batch/lot no. G005669 expiry date: 31-JUL-2013 and dose 3 on 20-MAR-2012 (batch/lot no. G014502). On 20-SEP-2011 (post dose 1) the patient experienced a swollen red arm at injection site, headache, tiredness and flu like symptoms. Attended GP 3 weeks later with cough, sore throat, discomfort and sticky eyes. The patient symptoms got worse over the following 3 days with swollen glands, sore ears and chest, severe abdominal pain and pressure pains in her head and joints. She was treated with AUGMENTIN, Fucithalmic and otosporin. The reporter indicated that the patient''s symptoms were very severe for 7 weeks before subsiding however headaches, abdominal pains and mood swings continued. On 17-JAN-2012, post dose 2, the patient experienced continuous gastritis, diarrhea, abdominal tenderness, menstrual cycle changes- became very heavy and irregular, increased mood swings, very tired and finding it hard to concentrate in school. The reporter indicated that these symptoms lasted for 6 weeks and was also sent to A and E. On 06-APR-2012, post dose 3 on 06-APR-2012 the patient experienced pressure pain headaches, severe gastric discomfort flu like symptoms and fatigue. The reporter indicated that these symptoms lasted for 3 weeks before subsiding but pain was still persistent in abdominal area. She has also suffered with persistent rashes, inflammation of the skin and lymphatic system, urticarial, severe leg pain, sore hips, sore eyes, feeling faint/dizzy and fainting, sore back, continuous nausea, brain fog, hair loss, sore hair line, polycystic ovaries, hand cramping, numbness in toes, knees and calves, itchy skin, bruising easily, very fast blood flow from cuts, very slow healing, lips swollen, cut and infected form seizures while sleeping, blisters in mouth, insomnia, muscle twitching in face and all over body, involuntary movements, swollen throat, unable to walk at times, pressure pain in head, sore ears, very sensitive to sound, photosensitivity to light, severe anxiety, fast heart beat, irregular heart beat, ear aches, very sore breast, sensitive to heat and cold, irritability to heat and cold, skin crawling, brain fog, unable to process what people are saying, unable to focus or read, sore jaw and teeth, severe weight fluctuation, candida and excessive discharge and unable to walk due to severe pains in legs. At the time of reporting the reporter indicated that the patient''s symptoms were persisting.

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