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Life Threatening? No
Write-up: Information was received on 04-FEB-2016 from Sanofi Pasteur MSD (Mfr control # 2016000750) as a part of business agreement. This case was received from the health authority on 01/Feb/2016 with reference number IE-HPRA-2016-025742. Initial report was received by the RA on 16/Jan/2016 from a member of the public which concerns a 13 year old patient who experienced headache, limb discomfort, injection site erythema, fatigue, myalgia, muscular weakness, abdominal pain, ovarian cyst, dizziness postural, alopecia, body temperature decreased, peripheral coldness, muscle spasms, lymphadenopathy, paraesthesia, tremor, feeling abnormal, memory impairment, chest pain, tachycardia and temporomandibular joint syndrome following vaccination with GARDASIL. Concomitant medications: none. Medical history/concurrent conditions: The patient had glandular fever at time of vaccination. Antibiotics given 3 weeks prior in hospital. The patient was vaccinated with three doses of GARDASIL at a dose of 0.5ml via intramuscular route between 01/Oct/2010 and 04/Apr/2011. Dose 1 and 3: batch number NN40800, lot number NM10090, expiry date 31-JAN-2013. On 01/Oct/2010, the patient experienced a headache, heaviness in her arm and erythema at the injection site. This persisted for 2-3 days and occurred after re-occurred after dose 2 and 3. The patient took paracetamol to relieve same. The patient''s headache continued and occurred intermittently over a long period of time but is resolved now. The patient experienced fatigue post vaccination that was ongoing at the time of reporting. The patient experienced generalised muscular pain and weakness in her neck, back and shoulders on 01/Oct/2010 that was also ongoing at the time of reporting. The patient takes analgesia and alternative treatments for same and also has physiotherapy. Amitriptyline and CYMBALTA were also given. The patient experienced abdominal pain and ovarian cysts on 01/Feb/2013. The patient underwent surgery in Sep/2013 and was started on OVRANETTE to regulate and ease pain. The patient also experienced dizziness on standing, lowered body temperature, cold extremities, spasms in lower limbs, swollen lymph glands in neck and armpit, paraesthesia in arms and legs, tremor in arms, brain fog difficulty remembering, chest/rib pain with tachycardia (ongoing intermittently "had an ECG" results not provided), TMJ and alopecia (used topical hair products to treat) that were all ongoing at the time of reporting. The patient was diagnosed with fibromyalgia/pain amplified syndrome in 2015. The patient is currently having ongoing neurological tests and her hospital admissions are increasing. The patient outcome was reported as not recovered/not resolved.
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