Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pulmonary hypertension, Pulmonary oedema, Respiratory distress, Sepsis, Speech disorder
Clinical narrative: This subject is a 75 year old female who was admitted to the hospital due congestive heart failure while enrolled in a study. The subject has received two doses of RSV vaccine or Placebo. Administration dates not reported. The subject developed moderate congestion with fluid build up in her lungs and was admitted to the ICU with a diagnosis of congestive heart failure on 2/8/04. Subject's sodium was also low at 106. The congestive heart failure was reported by the investigator as life threatening and not related to the study vaccine. Additional info received on 2/13/04. Subject received two doses of RSV vaccine or Placebo and Influenza vaccine with the last dose on 10/24/03. Dates of first dose 10/31/02. Subject developed congestive heart failure 94 days post immunization and was admitted to the hospital on 1/26/04, was transferred to the ICU on 2/8/04. Subject remains in ICU. On 1/12/04 breathing tube and feeding tube were removed. She is breathing well on her own. X-rays are being done daily and she is still on IV antibiotics. Seriousness not reported. Subject is recovering and will continue in the study. Additional info 2/20/04. The congestive heart failure was reported by the investigator as life threatening and not related to the study vaccine. Additional info received on 2/20/04. Subject was released from ICU and returned to the regular medical floor. She complained of dysphagia and difficulty with speech since feeding tube and breathing tube were removed and is mildly disoriented (responsive to commands). The subject is recovering and will continue with the study. Additional info received 2/27/04. Diagnosis: A-fibrillation, severe aortic stenosis, severe cardiac and bronchial asthma with congestive heart failure. Echo report on 2/9/04: Impression 1. Calcified degenerative aortic valve disease with moderate aortic valve stenosis with estimated aortic valve area of 0.9 cm squared and mean gradient of 24MMhg. 2. Mild bi-atrial enlargement, normal left ventricular size with hyperdynamic left ventricular hypertrophy.3. There is evidence of left ventricular diastolic dysfunction, moderate aortic valve stenosis, aortic valve of 0.9cm squared. Mild mitral and tricuspid valve insufficiency and mild pulmonary hypertension by doppler. Subject's breathing is extremely poor and is scheduled to have a tracheotomy and feeding tube inserted. She has been non verbal for the past 2 1/2 weeks, but seems to hear and comprehend better now. Mucus is being flushed from her lungs every 24 hrs. Resistant to massive doses of corticosteroids. Additional info received on 3/1/04. Tracheotomy was performed on 2/27/04. A gastric feeding tube was also scheduled to be inserted however she is on Coumadin and her bleeding time was too high to have procedure done. It will be performed once her bleeding time is controlled. Investigator has assessed the event as life threatening, unrelated to the study vaccine. Additional info received on 3/9/04. Gastric feeding tube placed, date of procedure unknown. Subject was extubated and receives breathing treatments every 4 hrs. She remains nonverbal and can now swallow. Antibiotic therapy continues. Subject has started antidepressants as well as Coumadin. Subject's blood sugars have been elevated and Insulin is being administered prn. Subject's recovery is ongoing and has been discharged to a long term acute care hospital (exact date not reported). Additional info received 3/15/04. Subject expired on 3/12/04, 140 days post immunization while in the acute care hospital. Diagnosis: Congestive heart failure. Awaiting death certificate. The subject's death due to congestive heart failure was assessed by the investigator as unrelated to the study vaccine.  Additional information received Mar 29, 2004. Discharge summary from Jan 30, 2004 to Feb 7, 2004 Discharge Diagnosis: The patient status post L2 through L 5 laminectomy and decompression performed. 1.The patient is mediclaly and surgicaly stable postop. 2. Patient with evidence of atrial fibrillation as well as signifant pulmonary deficits at the time, transferred to the acute medical service for stabilization. Patient also noted to have hyponatremia at the time. Hospital course: The patient was begun on intensive physical and occupational therapies as well as utilizing speech and nursing services for all of her deficits. During the hospitalization, the patient made good progress in her rehabilitation. The patient however did have low sodium level which at its lowest point was at 108. She also had evidence of some mild respiratory distress on the 7th of February. The patient was evaluated by the medical service and subsequently was tranferred to the medical service secondary to atrial fibrillation as well as some respiratory distress and significant hypoatremia was noted. Disposition: The patient ws transferred to the acute service on the 7th of February. Additional ifnromation received 7 April 2004. Jan 26, 2004: Admitted to hospital for elective spinal surgery. Feb 7, 2004: Discharge from rehab to ICU. Feb 17, 2004: Discharge from ICU to acute care (hospital floor). March 5. 2004: Discharge from hospital and transferred to acute care facility. March 12, 2004: Subject expired at acute care facility. 8 April 2004- Upon internal review from information received on 29 March and 7 April the subject's hospitalization for spinal surgery due to antero-spondylalisthesis and lumbar spinal stenosis will be combines into report 2004-00471. The subject was admitted to the hospital for elective surgery on 26 January 2004, 94 days post immunization. Subject had an MRI (date not reported) of the lumbar spine which showed severe spinal stenosis at the L4-5 level, with evidence of severe ligamentum hypertrophy at the lumbar spine resulting in lateral recess and neuro foraminal stenosis. She underwent a bilateral L2, L3, L4, L5 laminectomy with exploration/decompression L2-3, L3-4, L4-5, L5-5 neuro foramen. Additional information received on 4/14/04: Follow up report and Death Certificate. Subject wa originally diagnosed with Congestive Heart Failure however developed Pneumonia which led to Sepsis. Sepsis was the final cause of death which was secondary to Pneumonia, organism unspecified CU. Additional information received 4/29/04 Discharge summary report for admission to ICT on 2/7/04 and discharged from ICU to Acute care facility 3/5/04. Discharge Diagnosis: 1) Lumbar laminectomy post-operative day 40. 2) Severe hyponatremia, which has resolved. 3) Ventilator-dependent respiratory failure. 4) Severe chronic obstructive pulmonary disease, FEV 1.0 L, which is 50% of predicted, FVC 1.93, 70% of predicted. 5) Atrial fibrillation. 6) Moderate to severe aortic stenosis. 7) Myopathic neuropathy syndrome. 8) Hyperlipidemia. 9) Hypertension. 10) Osteoporosis. 11) ALBUTEROL allergy and possibly AMPICILLIN allergy. 12) Obstructive sleep apnea syndrome. 13) Anemai. 14) Thrombocytopenia. 15) Candida-albicans in sputum. 16) Mild hyperglycemia/diabetes mellitus 2. 17) Tracheostomy post-operative day 6 and percutaneous endoscopy gastrostomy tube post operative day 1. Discharge medications: Diflucan, Verapamil, Zovirax, Prevacid, Xopenex, Solu-Medrol, Atrovent, Free water, Bacitracin ointmen, Trach collar 30% as tolerated, Ventilator, Tylenol, Regular Insulin sliding scale. Subject was aformentioned diagnosis 40 days ago was seen when she had  change in mental status and respiratory insufficienty. She was transferred urgently for these complaints to the intensive care unit, and she was found with a sodium of 109. She was intubated and treated agressively. Her sodium was gently repleted to the normal levels. SHe has had difficulty with her cardiopulmonary status, particularly respiratory failure requiring Bi-PAP. Tracheostomy was performed six days ago and a PEG-tube was placed for nutrition. Patient had slight atelectasis in the left lower lobe which was likely due to the fact that she has been breathing spontaneously on Trach collar, but not taking deep breaths. Treated with a ventilator at night per the aforementioned settings. Subsequent medical care under the supervision of doctor. The family has been informed of diagnosis and prognosis. Details of the case has been discussed with the patient's son. A cardiology consultation should be obtained to optimize cardiopulmonary status, management of aortic stenosis and atrial fibrillation. Coumadin anticoagulation should be re-initiated.