Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Electrophoresis protein normal, Eyelid ptosis, Guillain-Barre syndrome, Haemoglobin decreased
Clinical narrative: Initial Health Authority report (reference number 124820) received on 08 Oct 2010. This polymedicated patient with medical history of schizophrenia, hypertension and dyslipidemia was vaccinated with S-OIV FOCETRIA (batch number 0902201) on 04 Dec 2009. The patient had received seasonal flu vaccination (manufacturer and batch number unknown) on an unspecified date. On 23 May 2010, the patient developed acute inflammatory demyelinating polyradiculoneuropathy consistent with Miller Fisher syndrome which led to hospitalization. The patient was showing diplopia and paresthesia of upper left limb as of date of this report. Final outcome of the events was reported as condition improving. Follow-up Health Authority received on 19 Oct 2010: This patient with medical history of schizophrenia since 1990, arterial hypertension, hypertriglyceridemia, recurrence of bronchitis episodes and underwent surgery for inguinal hernia in 2009. It was reported that, it was not possible to establish precisely the date of administration of the seasonal vaccine due to the fact that the vaccine administered privately; presumably the administration occurred about the beginning of Nov 2009 because the patient went for administration of the pandemic vaccine in Nov 2009, but the administration actually occurred on 04 Dec 2009, four weeks after the seasonal vaccine. On 23 May 2010 diplopia and paresthesias of the hands, bilateral developed. On 25 May 2010, worsening of diplopia, onset of palpebral ptosis on the right eye, and hyposthenia of the left lower limb occurred. For these reasons the patient went to the emergency department. The patient was afterwards admitted to the hospital. During the hospitalization, brain computed tomography scan and brain magnetic nuclear resonance was performed and both exams were within the normal limits. A progressive worsening of the palpebral ptosis, which progressed bilaterally; onset of paresthesias in the left foot, and deviation of the rima oris was observed. The patient was therefore, transferred to the neurology department. At the time of the admission in the neurology department, the patient showed bilateral opthalmoplegia, peripheral deficit of the VII cranial nerve on the left side, mild deficit closing the right eye against strength, absence of segmental deficit of strength in the upper limbs, proximal hyposthenia of the left lower limb (2/5), and diffuse areflexia. There was no deficit of the discriminative sensibility on an unspecified date. Examinations performed during hospitalization showed, haemato-biochemical profile with normocytic anemia and haemoglobin 12.5 g/dl (versus 13.5-17.5), triglycerides was 203 mg/dl (versus < 150). The proteins electrophoresis was within normal limits. Evaluation of the cephalorachldian fluid and physical-chemical evaluation limpid aspect was as clear water, proteins 1.65 (versus 0.15-0.60), glucose 74 mg/dl (versus 40-70), chloride 121 mEq/L (versus 115-130), white cells 10 (versus < 4), index of link 0.68 (versus < 0.75), permeability barrier index 44 (mild barrier damage), albumin 991 mg/L (versus 150 273), IgG 191.8 (versus 24 45). On 03 Jun 2010, electrocardiogram of sinus rhythm, heart rate was 90 beat per minute. Chest X-ray performed in bed on 04 Jun 2010 showed absence of active parenchyma lesions. Lungs were in place. Electromyography on 03 Jun 2010 showed neurophysiologic picture compatible with possible demyelinating neuropathy with sensitive and motor involvement type acute polyradiculoneuritis. The patient also experienced persistence of mild vertical dipolpia in the right gaze, and occasional paresthesias on the left upper limb on an unspecified date. On 17 Jun 2010 the patient was transferred to the functional rehabilitation department for global rehabilitation. The last neurological visit performed on 17 Jun 2010. The neurological check up planned within six months. The patient was discharged on 20 Jul 2010. The outcome of event miller fisher syndrome was reported as completely recovered while outcome of other events was not reported.