Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Convulsion, Diabetes mellitus, Embolism, Gastrointestinal disorder
Clinical narrative: This subject is a 69 year old female who was admitted to a progressive care unit due to seizure while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted Respiratory Syncytial Virus Vaccine versus an RSV vaccine adjuvanted with Aluminum Phosphate When Administered Concomitantly with a Licensed Influenza Vaccine in High-Risk Adults > or = 65 years of age. The subject received the second dose of RSV vaccine or Placebo and Influenza vaccine on 11/7/03. The first dose not reported. The subject experienced a seizure 80 days post immunization and was taken to the ER on 1/26/04. Subject had sonorous respirations and was unresponsive with persistent facial twitching. Treatment included Ativan, Dilantin, and oxygen. Subject was transferred to Progressive Care Unit/Telemetry. Clinical impression was epileptic seizure, cerebrovascular accident, postictal state, uncontrolled insulin dependent diabetes, hypertension. The seizure, cerebrovascular accident and uncontrolled insulin dependent diabetes were reported by the investigator as unrelated to the study vaccine. Additional information received 4/2/04. Subject was admitted to hospital on 1/26/04 for seizure and respiratory failure and was then transferred to a burn center for a skin problem associated with the epileptic medicine that she was receiving. Treatment for seizures included Dilantin. Subject expired at the burn center on 2/4/04, 9 days after admission and 89 days post immunization. Medical records not received by investigator as of yet. The respiratory failure and death were assessed by the investigator as unrelated to the study vaccine. Additional information received 4/6/04. Onset date of respiratory failure is 1/26/04. Additional information received 4/8/04: Date of death confirmed as 4/3/04. Exact cause of death and death certificate to follow.  Nurse follow up on 05/27/04 states: "ADD: Anemia, Renal failure, GI bleed, Embolism, Pneumonia, CHF, Septic shock, Hemiplegia, GERD, Infect Bacterial (ANEMIA, KIDNEY FAIL, HEM GI, EMB, PNEUMONIA, HEART FAIL RIGHT, SEPSIS, PARALYSIS, GI DIS, INFECT BACT)"  Follow up on 07/12/04 states: "Main diagnosis is Seizures. Pt was admitted to the hospital on 01/26/04 after family witnessed Grand Mal Seizure. MD verbally noted respiratory failure upon admission also. Pt was discharged from hospital 02/19/04 to a nursing home and then to a burn center for skin problems associated with epileptic medication reaction. Pt expired at the burn center on 04/04/04."  Follow up on 08/06/04 states: "Subject expired at the burn center on 04/02/04, 67 days after admission and 147 days post immunization.  Onset date for respiratory failure is 01/26/04. Date of death confirmed as 04/02/04. Exact cause of death and death certificate to follow. Main diagnosis is seizures. Pt was admitted to the hospital on 01/26/04 after family witnessed Grand Mal Seizure. MD verbally noted respiratory failure upon admission also. Pt was discharged from hospital 02/19/04 to a nursing home and then to a burn center for skin problems associated with epileptic medication reaction. Pt expired at the burn center on 04/02/04 (corrected). Discharge summary: Admission date 01/26/04, Discharged date 02/19/04. The 69 year old subject had a grand mal seizure lasting for 10 minutes and was brought to the ER and treated with Dilantin and Ativan. Subject had a constricted pupil, peripheral pulses decreased. CNS-drowsy, responded to tactile stimuli. Left sided weakness noted. Detailed exam could not be performed due to sedation by Ativan. Tests performed included an Ultrasound of Kidney-unremarkable, CT of the head without contrast-mild atrophy-VQ scan-probability of pulmonary embolism considered quite low, chest x ray, one view on 01/26/04 poor inspiration, patchy infiltrates versus alveolar edema in the upper lobes. Left lower extremity venous Doppler-DVT, left common femoral vein and proximal superficial femoral vein. CT of the brain-no acute abnormalities. Electrocardiogram showed no acute process. Echocardiogram had no obvious RWMAs at rest. Probable C LVH. Trivial degenerative changes, aortic and mitral valves. Technically difficult to perform study. Hospital course: admission orders in addition to routine PCU orders included neuro checks, seizure precautions, IV fluids, nothing by mouth, Foley catheter, O2 protocol, sliding scale Humulin R insulin coverage SC, IV Lopressor and additional Regular Insulin and also Zofran IV prn nausea. Consult from neurology with his impression of breakthrough seizure most likely secondary to metabolic abnormalities, elevated glucose, history of seizure disorder secondary to old CVA, residual left hemiparesis. A PICC line by interventional radiology which was carried out. The pt was confused/disoriented. Had no localized neurologic signs.  Th ept was cultured and put on IV Rocephin. She had increased temperature of 104.5. She was found to have a DVT, left leg.  An infections disease consult was obtained with impression of fever most likely secondary to aspiration pneumonia after seizure disorder. Recommended Ceftriaxone addition to Clindamycin. The pt was alert but nonverbal.  Did not follow commands.  Blood sugars were over 300. Dilantin level was 8.4, she was given extra dose of Cerenex. House physician was called to see the pt the am of 01/29 for hypertension with SBP in the 180s. She was also hyperglycemic at 380. She was given Lopressor. He felt she might benefit from a spinal tap. Recommended repeat of Ct of the head and follow up with neurology. En route from CT scanner her nurses reported the pt became apneic. Pulse oximetry dropped to 78. Code Blue was called when the pt returned to the room. Upon arrival of house physician she was stable. Pulse oximetry was 98%. She was transferred to ICU for closer monitoring with consideration for possible need for intubation for airway protection. A VQ scan showed low probablity for pulmonary embolism. ECG with QT prolongation which he felt probably related to metabolic disturbance specifically hypokalemia, associated drug effect an/or CNS effect. He recommended repleting K and magnesium, additional diagnostic studies, adjustment of blood pressure medication. CT scan showed no change from study of 01/26/04. No acute lesion. Temperature was 103.8, white count 10.1. Doctor felt we should presume meningitis. Ampicillin was added. Clindamycin was discontinued. LP was recommended. Urologic consult was obtained re hematuria on anticoagulation therapy for DVT. Recommended holding of heparin until urine cleared and then attempt to restart. If recurrent hematuria, then consideration to renal ultrasound. A nephrology consultation was obtained, his impression of seizure disorder, fever, fuled out aspiration pneumonia, diabetes poorly controlled, labile hypertension, on Cardene; mild hypoartremia. He recommended no free water and IV fluids, change of all IV medication to normal saline and if sodium dropped further, then consideration to discontinuation of Paxil. He also recommended daily BMP. The pt was more alert and smiling, verbalizing; temperature was 102.8.  Cardiology recommended a Greenfield filter. K was low and being repleted. IVC filter was place on 01/30/04 without complications. Hypoatremia was improving. K was being repleted. Creatinine was 1.5. Sugars were over 300. She again had hematuria on heparin. Urology recommended discontinuation of anticoagulation since Greenfield filter was placed. The pt's husband and daughter refused a lumbar puncture. They wanted to wait until the following week. The pt was much more awake and alert, oriented, followed commands with no further seizures. Dilantin level was therapeutic. Doctor felt there was no urgent need for lumbar puncture. Cardiology recommended start of PO fluids, assessing swallowing function, continuation of beta blocker and ACE inhibitor, resumptoin of low-dose anticoagulation and transfer out of ICU. The pt had no complaints. Was awake. Had no diarrhea. Urine was clear. Ultrasound of the kidney was a limited study; kidneys appeared normal. Outpt cystoscopy was recommended. Medication was adjusted. Creatinine was stable. She had no further hematuria. Cysto in office was recommended and discussed with pt husband.  She had no cardiac symptoms, Coumadin was resumed.  Wound care consult had been requested. She also had presumptive C.difficile colitis for which she had been treated with Metronidazole and Flucanazole for fungal dermatitis had also been administered, both of which were discontinued. Pt had no further breakthrough of seizures. Wound care was being carried out for bilateral buttock maceration, stage II ulcer at base of spine. Medications were adjusting for hypertension.  The pt was stable for discharge to the nursing home on 02/19/04.  Discharge Diagnosis: Breakthrough seizures, aspiration pneumonitis, suspected meningitis, suspected C.difficile colitis, fungal dermatitis, Subtherapeutic dilantin level, old cerebrovascular accident with left hemiparesis and known seizure disorder, decubitus ulcer, deep venous thrombosis, left lower extremity, greenfield filter placed, hypertension/hypertensive heart disease, diabetes mellitus type 2 non insulin dependant, obesity, coronary artery disease, status post myocardial infarction, sleep apnea, history of gstroesophageal reflux, chronic obstructive pulmonary disease, hypoatremia mild, hematuria on anticoagulation, QT prolongation secondary to metabolic disturbance specifically hypokalemia, allergy to E-Mycin and Tetracycline.  Complementary information form: SAE respiratory failure start date 01/26/04, stop date 02/19/04. The following events are all pre-existing and are not SAEs (part of history): cerebrovascular accident, uncontrolled insulin dependent diabetes, hypertension. Death certificate will be sent when available. 07/30/04: Upon internal review, correction to the date of death in the narrative was made to 04/02/04.  Cross reference with cases F20030006, 2004-00009.