Age: 79.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Gait disturbance, Guillain-Barre syndrome, Movement disorder, No reaction on previous exposure to drug
Clinical narrative: We received from a health care professional via the Medical Communication the following information on 07 APR 2008: A 79-year-old man, born on 03 OCT 1928, was vaccinated with Fluvirin, batch-no. 80684, i.m. on 29 OCT 2007.  On 12 NOV 2007 the patient started to have problems.  He had trouble walking, swallowing and could not move legs at onset of symptoms.  Patient was hospitalised for evaluation, and received tracheotomy as result of difficulties. Over the past three months the patient has had some improvement in leg movement and swallowing.  Previous vaccination(s) was (were) well tolerated.  Company assessment: Seriousness criterion: hospitalisation.  Causality: insufficient data.  We have not enough medical details to assess the case definitely.  Expectedness assessment according to SPC/US label: The reported symptoms are not expected after vaccination with Fluvirin.  No change in benefit-risk-ratio.  No measures necessary.  5/2/08 Reviewed hospital medical records for 12/8/2007-2/4/2008. FINAL DX: severe dysphagia; chronic aspiration; LLL abscess; congestive cardiomyopathy, possibly related to alcoholism; septic shock; cardiogenic shock; shocked liver syndrome; urinary retention w/catheter; hyponatremia; thrombocytopenia. Records reveal patient experienced weakness w/falls, fatigue, anorexia, decreased oral intake, cough & secretions w/food or liquids, bilateral leg edema w/bluish discoloration all progressing to the inability to walk over approx 2 weeks.  Denied alcohol for past 10 days. Ischial pressure ulcers noted on admission along w/peripheral neuropathy likely noted to be related to alcohol abuse. Consults: wound care, neuro, cardio, ID, palliative care, uro.  Developed tachycardia, hypotension, worsening infiltraes & sepsis.  Transferred to ICU by 12/11/07 on pressors, antibiotics, TPN, thoracentesis & BiPap, never intubated.  PEG tube inserted.  Improved minimally & transferred to rehab facility on continued IV antibiotics.  Patient refused PT/ST/OT or further neuro w/u but accepted PT at transfer.  5/2/08 Reviewed hospital medical records for 2/17-2/21/2008. FINAL DX: aspiration pneumonia secondary to severe dysphagia; dysphagia; poor nutrition; diarrhea secondary to poor oral absorption of PEG feeds; abdominal pain secondary to tube feeds; HTN; depression; Stage II sacral decubitus. Records reveal patient experienced severe resp distress & hypotension due to recurrent aspiration while at rehab facility. Tx w/IV antibiotics & supplemental O2.  Improved minimally & transferred back to rehab facility.   Patient returned to hospital 2/21-2/27/2008. FINAL DX: aspiration; neuromuscular disease unknown etiology. Records reveal patient readmitted for gen weakness & altered mental status.    Transfused for anemia.  Intubated & on mechanical ventilation.  Neuro consult done & suspected chronic inflammatory demyelinating polyneuropathy.  Recommended transfer to higher level of care for further neuro w/u.    4/29/08 Reviewed hospital medical records for 2/27-3/21/2008. FINAL DX: motor/sensory axonal neuropathy of unclear etiology; muscle fibrosis c/w possible muscular dystrophy; aspiration pneumonia, resolving; left anterior uveitis left eye, resolving; multiple electrolyte abnormalities; anemia related to chronic disease & poor nutrition. Records reveal patient experienced approx 5 mos of progressive weakness, dysphagia & weight loss.  Now had PEG feeding tube.  Had 2 previous admits in outlying hospitals.  Intubated & in neuro ICU.  Exam revealed left eye w/corneal clouding & ptosis.  Areflexic.  Severe atrophy bilateral LEs.  Increased tone right side.  Unable to walk due to weakness. Consults by rheum, ID, ophthalmo & neuro.  All rheumatology testing was neg. Trached 3/7/08.  Transferred for further rehabilitation. .