Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Bacterial infection, Cough, Deep vein thrombosis, Dyspnoea, Hypoxia
Clinical narrative: This subject is a 72 year old male who was admitted to the hospital due to Pneumococcal Pneumonia while enrolled in RSV11 study. The vaccination received prior to the event was Influenza vaccine lot # U1137HA on 10/17/03. The subject also received RSV vaccine or Placebo and Influenza vaccine on 11/1/02. The subject developed shortness of breath, fever and cough 38 days post immunization and was admitted to the hospital on the same day, 11/24/03. Diagnosis of Pneumococcal Pneumonia. Chest x-ray showed left lower lobe pneumonia. Subject was started on Rocephin, Zithromax with good response. Subject is also on bi-pap. The subject's outcome is ongoing. The Pneumonia was reported by the investigator as possibly related to the study vaccine. Additional info received 12/11/03. Subject was intubated and on the ventilator 11/26/03 thru 3/12/03. He was diagnosed with a pulmonary embolism at that time. He was started on a heparin drip that continues at this time and also started on Coumadin. A sputum culture was obtained 9/12/03 with pending results. Subject will be transferred to rehab before he is discharged home. Diagnosis: Pneumococcal pneumonia, pulmonary embolism. The Pneumococcal pneumonia and pulmonary embolism was assessed by the investigator as possibly related to the study vaccine. Additional info received 12/12/03. Complimentary Information Form: confirmed that the SAE is possibly related to RSV vaccine. Confirmed that the SAE is not related to the Influenza vaccine. Last administration date before the SAE for RSV vaccine is 17/10/2003. Follow up SAE form provided. Additional information received Jan 7, 2004. Medical records: The pt was admitted to the medicine service for severe chronic obstructive pulmonary disease exacerbation. He was mechanically intubated for oxygenation and ventilation purposes. He did well on the ventilator, however, due to his severe chronic obstructive pulmonary disease, weaning him from the ventilator was quite difficult. he was extubated to face mask oxygen where he did well. The pt was placed on bilevel at night which significantly help his oxygenation-ventilation status and likely help by contributing to relief of his severe pulmonary hypertension. He was maintained on Flovent, Combivent, and Serevent, and continued to use these as nebulizers. His oxygenation levels were stable and he was eventually weaned down to approximately 2 L of oxygen by nasa cannula. The pt did have group A streptococcus bacteremia for which was treated with Zosyn. His cultures did eventually clear and he remained afebrile and stable off of the antibiotic. The pt did have a deep venous thrombosis diagnosed by an ultrasound in 11/26 in the left common femoral vein. The pt therefore required long ter anticoagulation and started on Heparin and then eventually Warfarin. There were also some questions whether he did have apulmonary embolism, however, the CT dated 11/26 did not show any evidence for pulmonary embolism. The pt was severely deconditioned after being taken off the ventilator and required significant pulmonary and physical rehabilitation. Procedures: 1. Intubation 2. CT scan of chest, abdomen, and pelvis. 3. Ultrasound, left lower extremity. 4. Transthoracic echocardiogram with an ejection fraction approximately 40% with increased right ventricular volume and moderate pulmonary hypertension with PA systolic of 40 to 50 mmHg. Discharge medications: Combivent, Lovenox, Warfarin, Flovent, Aspirin, Pepcid, Serevent. Subject recovered and was discharged from the hospital into a rehabilitation center 17 days later on Dec 11,2003. Additional information received on Mar 2, 2004 Subject was admitted to the ICU with severe SOB, fever. Chest X-ray showed a right lower lobe infiltrate, most likely representing inflammatory process/pneumonia. He was on the ventilator from 26/11/03 to 02/12/03. Sputum culture grew Beta Hemolytic Strep Group A. Blood Cultures grew Alpha Strep, not pneumococcus and staph. Hominis both contaminates according to PI. Arterial Duplex performed on 11/26/2003 showed left lower extremity deep venous thrombosis of the common femoral vein. Chest CT Scan on 11/26/2001 confirmed areas of atelectasis in the right middle lobe, and nasal segments of the left lower lobes bilaterally. There is also focus on density in the anterior segment of the right upper lobe. There is no pleural or pericardial effusion or pulmonary embolis. Treatment included Azithromycin, Ceftriaxone, Penicillin G, Eosyn, Heparin IV and Solumedrol. Subject recovered and will continue in the study. The Group A Beta Strep pneumonia and deep vein thrombosis was reported by the Investigator as possibly related to the study vaccine. Additional documents available with source file.  Medical records: Admission date 11/24/03-Discharge date 12/11/2003, Chest CT W NON IONIC (11/26/2003) Arterial duplex Le Bilat 11/26/03, Progress report, Laboratory results: 11/24/2003-12/09/2003, Chest single view VW port (11/25/2003) Chest PA/Lateral (12/9/2003)