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Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # FR-1577272925-2016008947) on 09-SEP-2016, as a part of business agreement. Case received from a other health professional via Agency under the ref number PC20160517 on 05-Sep-2016. This case was reported in the context of data collection in the RCND. A 16-year-old (also reported as 18-year-old) female patient received GARDASIL (Lot Unk, Dose 1) via intramuscular route on 12-Jul-2009 and GARDASIL (lot Unk, Dose 2) via intramuscular route in 2010. Other suspect products included: REVAXIS (Lot Unk) on 09-Mar-2010; ENGERIX-B (batch number 1704B9, Dose 1) administered via intramuscular route on 18-Jan-1996; ENGERIX-B (batch number 1704B9, Dose 2) administered via intramuscular route on 15-Feb-1996; ENGERIX-B (batch number 1704B9, Dose 3) administered via intramuscular route on 18-Jul-1996; INFANRIX (batch number unknown) on 21-Dec-2004; INFANRIX (batch number unknown) on 19-May-1999. In 2009 she had received a first dose of GARDASIL and one year later a booster dose. In 2010, onset of first episodes of asthenia that lasted 3 weeks and associated to hypotension (systolic value at 8). In 2010, aggravation of health status with fatigue, kidney pain and diagnosis of thyroiditis Hashimoto with abnormal TSH. Levothyrox was initiated. In 2013, malaise with suspicion of epileptic fit. From 3Nov2014 to 5Nov2014 she had been hospitalised. She had difficulties in walking needing to rest every 10 min, feeling of tingling of the forearm and loss of sensation in hands, fits of pain starting in occipital area and irradiating towards face. She presented also sleeping disorders and cognitive disorder. The patient was admitted to hospital on 03-Nov-2014. Medical history of kidney stone that aggravated into pyelonephritis in 2013 and associated to renal colic with medical care. Slight renal insufficiency and appendectomy. Additional investigations included: Ultrasound Doppler Cervical U/S showed thoracobrachial outlet syndrome bilateral but predominant on left side on 05-Mar-2013; Nuclear Magnetic Resonance Imaging normal on 27-Mar-2013; blood Test Antinuclear antibodies positive (Hep 2 and immunofluorescence test positive on 03-Nov-2014; Electromyogram Unremarkable including evoked potentials (auditory, visual, somatosensory, laser, electroneuromyography) on 04-Nov-2014; Positron Emission Tomogram Hypometabolism predominant in corpus amygdaloid and hippocampus, and to a lesser extent sylvian area (frontal, postero inferior and upper temporo areas) and cerebellum on an unknown date; Blood Thyroid Stimulating Hormone abnormal on an unknown date. At clinical examination, outstretched arms were maintained for 5 sec and associated to right myoclonia, slowed sensitivity to finger-nose test, constant contraction of tibialis anterior tendon, positive Romberg test (positive YF), loss of epicritic sensitivity of the lower limbs extremities, proprioception of the thumb modified, heel/knee normal with open eyes and abnormal with closed eyes, no hypotonia, cranial nerve normal. Conclusion provided in Agency report was that the patient presented with myofasciitis macrophagic and that since 2013 she was forced to stop studying. The patient''s outcome with regard to events myofasciitis macrophagic and Hashimoto thyroiditis was reported as Not recovered/not resolved. The outcome of other reported events was unknown.
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