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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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