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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Case received from a pharmacist on 24-NOV-2011 and medically confirmed. A female patient aged 14 or 15 years old with no relevant medical history had received the three doses of GARDASIL (batch number not reported) according to the recommended schedule, and the third dose in January 2011. On an unspecified onset of time after the third dose, she experienced spasmophilia, painful muscle spasms, anxiety and extreme fatigue. For some time now she also developed insomnia and needed sleep inducing drug to fall asleep. She was also given analgesics and vitamins as corrective treatment. Computed axial tomography (CT) Scan was normal, so as the consultation at the ophthalmologist. It was noteworthy that the first two doses had been administered on unspecified dates, and the tolerance had not been reported. The patient used to be in good general health Status. At the time of reporting, the patient had not recovered. Follow-up information received on 19-MAR-2012 through PV form and laboratory reports. Case upgraded to serious upon the basis of the information received. The patient was 14 years old. She had received the first dose of GARDASIL (batch number NL53400, lot number NJ49370) on 14-SEP-2010 and the second GARDASIL (batch number NL50390, lot number NJ53440) on 08-NOV-2010. She received the third dose (batch number NN22980, lot number NK05070) via intramuscular route in the left deltoid on 09-MAY-2011. On an unspecified onset of time she developed fatigue, pain in neck, heaviness in legs, tetany fits and sleep disorder. Thyroid ultrasound was performed on 03-NOV-2010 and showed thyroid whose volume was at the upper limit especially the right lobe. Intraparenchymatous micro cysts of 2 to 3 mm in diameter were present in both lobes. There was no nodular formation. Thyroid goiter was suspected. Cervical spine computed tomography was performed on 26-MAY-2011 due to heaviness of both upper limbs prevailing on the right, without notion of trauma but following the cervical spine handling. It showed no significant disc or vertebral anomaly. Medullar magnetic resonance imaging (MRI) was performed on 09-JUN-2011 due to repeated malaises when stretching the neck associated with paraesthesia of upper limbs. Neurological examination and cervical CT scan were normal. MRI showed loss of cervical spine lordosis with discrete kyphosis. Cervical hyperextension showed a contact of the upper marrow with the cervical canal. Electroencephalography (EEG) performed on 01-JUL-2011 showed diffuse acute theta waves in hyperpnea but no asymmetry, focused or paroxysmal anomaly. The neurological examination concluded that there was no electrical neuromuscular anomalies. Lumbar spine MRI was performed on 16-JAN-2012 due to pain accompanied by formication in legs and trauma one month before. It revealed L3/L4 discopathy with marked central elevation which coming into contact with the dural sac and the L4 right and left emergencies. It also showed a small L4/L5 protrusion with no clear root impingement. Calibar canal was at the lower limit of the normal. The patient was given corrective treatment with CORTANCYL, VOLTAREN, paracetamol, omeprazole, and from 30-MAY-2011 she was also given HEPT-A-MYL tid during 15 days, CORAMINA-GLUCOSA 1 dosage from oad or bid in case of fit, and "ATEPADENE" bid during one month. On 06-JUN-2011, she was prescribed UVEDOSE 1 dosage form, L72 (homepathy) 30 drops at dinner and 60 drops before going to bed, and ADVIL tid if fever. Vaccination file was provided and was up to date. The reporter mentioned that the patient was unable to practice any physical activities during two months. It was noteworthy that no criterion of serious was ticked by the reporter. The events were considered to be disabling. Other business partner number included: E2011-07490. No further information is available.
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