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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Case received from a physician on 20-OCT-2011 and medically confirmed. A 17-year-old female patient had received the third dose of GARDASIL (batch number not reported) on an unspecified date. One month after vaccination, the patient experienced myalgia, shortness of breath and had no more strength. At the time of reporting, the outcome was not provided. To be noted that the patient was followed by a cardiologist, and that according to the patient''s mother, the events were due to the vaccine. Follow up information received on 24-JAN-2012: The patient was 14 year old at the time of the events instead of 17 as previously reported. The patient had received the first dose of GARDASIL (batch number not reported) on 01-MAR-2011, the second dose (batch number NM23050) on 27-MAY-2011, and the third dose (batch number NM45890) on 29-AUG-2011. She had concomitantly received NEISVAC-C (other manufacturer, batch number VN914776) on 18-JUN-2011. Starting in the middle of September 2011, the patient was found severe asthenia, concentration impaired, appetite disorder, menstrual disorder and movements disorder. The patient also experienced narcolepsy accompanied by fine movements disorder. The disorders rapidly deteriorated. The patient was referred to a cardiologist due to chest oppression and shortness of breath, and to a rheumatologist due to diffuse joint pain. She was subsequently hospitalized. Consultation at the cardiologist on 19-OCT-2011: The patient who used to practice high sporting activity up to the last summer presented since then severe asthenia with a need for prolonged sleep period. Furthermore, she also presented with malaises, some of them occurring just after practicing sport with a sensation of slow heart beat which necessitated that she sat down, then followed by lipothymia without loss of consciousness. Other malaises occurred when she was in a sitting position, during the meal, or even lying down. It was difficult to assess whether she had lost consciousness. There was no familial history of heart disease, in particular no history of rhythmology anomaly which could have led to early serious events. Blood pressure was 10.5-6, heart sounds were regular, there was no sound or pathological add-on murmur. Distal pulse could be heard, there was no cervical murmur, lung auscultation was correct. Electrocardiogram showed sinusal rhythm 94/min, PR interval 0-16, QRS axis superior to 40, supple repolarization, Q-T interval 0-28 for a theorical basis of 0-31. Carotid sinus massage did not show any hyper reflexivity. Echo doppler was reassuring with a good global and segmentary contractility and no stigma of pulmonary arterial hypertension, no shunt, no cavitary dilatation particularly left atrial. Doppler tissue imaging screening showed a mitral annulus normal. To be noted that the patient had experienced cutaneous hyper reactivity consequently to mosquito bites. The cardiologist suspected a possible tick bite which could lead to search for arguments suggestive of Lyme disease. 24h-ECG Holter monitoring was recommended. Consultation at hospital on 17-NOV-2011: The patient used to practice piano, dancing and sailing. During the last summer she had practiced sailing and cycling in a sport summer camp. To be note that the patient had started to have her periods from 9 years old to 11 years old. She now had her periods since the age of 13 under treatment with DUPHASTON which had recently been interrupted. On examination she presented with malaises with sensation of cardiac arrest. She presented with 4 malaises apparently with no prodrome, accompanied by hypersomnia (the patient slept for approximately 1 hour). When she was seen by her family and friends circle, she was found to have the sensation of white and cold hands and sweating. There was no notion of aura before these malaises, no loss of urine and no tonic-clonic movements. But the patient presented with postictal amnesia. The patient experienced pain and cramps at the level of the lower limb associated with sensation of locked knee. She also presented with fatigability and dyspnea exertional, as well as severe asthenia since the end of last summer. She stopped any leisure or sporting activity. Biological work-up, blood work-up, ionogram, thyroidal work-up and electrophoresis had been performed. Results were normal. There was no inflammatory syndrome. Lyme serology was negative. The patient had been seen by a rheumatologist who concluded to back pain on a growth spinal dystrophy with a slight kyphotic attitude for which she was followed by a physiotherapist. Cardiac work-up, including ECG, Holter and echocardiogram, was normal. Physical examination was strictly normal. Cardiac and pulmonary auscultation were normal. There was no peripheral adenopathy, no neurological anomaly and particularly no motor deficiency. The Osteotendinous reflexes were all present. There was no pyramidal irritation and no cranial nerve anomaly. The patient also presented with food disorders and difficulties in relationship with her family and friends. An electrophysiological work-up was performed on 23-NOV-2011, which was normal and which could not explain the pain that the patient felt in her left quadriceps. Hospital report on 06-DEC-2011: The patient was hospitalized in the paediatrics service from 22-NOV-2011 to 25-NOV-2011 due to asthenia accompanied by recurrent malaises. She had a history of scoliosis and congenital hip dislocation. In end of August 2011, during the weekend preceding the beginning of the school year, the patient experienced a malaise without loss of consciousness associated with dizzy spells and filmy vision which spontaneously resolved after 5 minutes of rest. A few days later, malaises were recurrent during a meal, without loss of consciousness and without prodrome, followed by falling asleep during approximately one hour. In the same time, the patient was found to have mechanical back pain which partially regressed under paracetamol as well as mood disorder, particularly characterized by arguing with her parents. Two repeated episodes of muscular cramps in the internal face of both thighs were also reported. Infectiolous work-up had been performed and was normal. On admission, physical examination was normal, particularly from a neurological standpoint, except for amenorrhea which lasted since one month. Clinical investigations were normal for biology except for a slight increase of Creatine phosphokinase at 736 on 22-NOV-2011 but which had reduced at 280 two days later. Hepatic work-up was normal. Patient''s evolution within the service: The patient reported two episodes of falling asleep. Physical examination was still normal. Epworth Sleepiness Scale was performed due to hypersomnia and revealed 8-10/24, i.e. moderate sleep debt. Check-up for malaises was completed by electroencephalogram on 24-NOV-2011, which was strictly normal with a normal somnolence and sleep for her age and a non REM stage after falling asleep physiologically. Electromyography did not show any anomaly either which could explain the pain that the patient felt. The neurologist specialized in sleep could not see any formal indication for the moment to treat a potential narcolepsy as the diagnosis was unlikely. The patient was seen by a child psychiatrist who put forward a dimension of depression without signs of seriousness characterized by a decrease in external investments and inexplicated crying when she was on her own. To be noted that episodes of malaises and falling asleep never occurred when she was on her own. The child psychiatrist suggested that the depressive symptomatology could explain at least partially the different malaises. The functional origin as only source of these malaises would only be confirmed once the patient would have seen the neurologist and if no other cause found to explain hypersomnia. The patient was discharged on 25-NOV-2011. The hospital report concluded to malaises and sleep disorder without aetoiology at the moment except for depressive syndrome. Brain MRI performed on 02-JAN-2012 did not find any patent anomaly. See lab data for further results. Consultation at the neurologist on 14-DEC-2011 (only the 1st part of the letter was received): the patient fell asleep either at school, during meals, and she reported that once she fell asleep while standing and speaking and that time her parents had difficulties in waking her up. Epworth Sleepiness Scale was 14. Both hospitalization and disability were reported as seriousness criterion. To be noted that according to the reporter, the suspected diagnosis was neurological disease induced by vaccination with GARDASIL or its adjuvants. The patient''s outcome was reported as deterioration. Follow-up information received from the neurologist letter via the patient''s mother on 08-FEB-2012: The patient''s mother had a history of thyroid cancer in remission, and her father and brother both experienced hypercholesterolemia. The patient started to have her periods from 9 to 11 years old but now experienced amenorrhea. There was no sleep paralysis, no hypnagogic hallucinations, no clear cataplexia although she sometimes needed to sit when she was walking, and no weight increase. Physical examination was normal. Funduscopy showed clear papilla. The neurologist concluded to excessive diurnal somnolence, and put forward three hypotheses: two organics, i.e. sleep pathology or linked to sleep deficiency (sleep lasted generally 7 hours), or psychophysiological hypersomnia. At the time of reporting, the patient had not recovered. Other business partner numbers include: E2011-06476. Additional information has been requested.
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