Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Anger, Asthenia, Cerebrovascular disorder, Guillain-Barre syndrome, Hypotension
Clinical narrative: An adult male alleges that he received an injection of FluShield vaccine "on or about" 01/04/2000 and developed "severe personal injuries, including paralysis from Guillain-Barré syndrome," 2 to 3 weeks post-vaccination. He also alleges that he "suffered great physical pain and mental anguish due to such injuries" and claims that "he has been left with permanent residual deficits." No further info was available at the date of this report. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by FDA. A 15-day follow up report received 04/23/2003 adds: Follow-up medical records received on 04/10/2003 via the pt's attorney provided medical history, concomitant medications, an event onset date, pt age at event, pt date of birth, dates of hospitalization, laboratory test results, and event course. A legal complaint was received from an attorney regarding a 63 year-old white male pt who received an injectin of FluShield vaccine on 01/04/2000. Concomitant therapy included Cozaar (Losartan potassium) and bumetanide for hypertension; Glucotrol (glipizide) for non-insulin-dependent diabetes, and Lipitor (atorvastatin) for hypercholesterolemia. The pt's medical history also includes smoking, renal insufficiency, and asthma. On 01/24/2000, the pt developed paresthesias in his legs with progressive weakness as well as tingling in this hands and facial area around his lips. On 01/26/2000, he was hospitalized in the intensive care unit to rule out Guillain-Barre syndrom/acute inflammatory demyelinating polyneuropathy, rule out cervical myelopathy. A CAT scan of the brain performed that day revealed mild cerebral atrophy with no evidence of tumor, intracranial hemorrhage, or infarct. On 01/27/2000, the pt was transferred to the intensive care unit of a second hospital facility for plasmaphoresis. An MRI of the brain performed that day was unremarkable; however, Guillain-Barre syndrom was not excluded. While hospitalized, the pt received 6 courses of plasmaphoresis and made 'slow but gradual' improvement of his numbness and weakness, with greater strength in his upper extremities than in his lower extremities. He reportedly 'responded well' to physical therapy. On 02/10/2000, he was discharged with a final diagnosis of Guillain-Barre syndrome to a rehabiitation facility for physical therapy. He was subsequently discharge home with a walker. Motor nerve conduction studies of the bilateral upper extremities and bilateral lower extremities performed on 06/12/2000 were 'markedly abnormal' and demonstrated polyneuropathy with axonal and demyelinating features. EMG of the right upper extremity was limited due to the pt's intoleerance to the examination but revealed normal right biceps and right pronator teres muscles. A physician's note dated 10/11/2000 indicated that the pt has permanent impairment of strength. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by FDA. Follow up on 08/15/2003: "Additional information was received from the plaintiff's attorney on 08/04/2003.  A medical consultant reviewed the patient's hospital admissions and medical records sent to him by counsel covering the time period of 01/27/2000-12/06/2000 and provided additional laboratory results.  He noted an MRI of the patient's spine on 01/27/2000 showed degenerative changes and small herniation at T8-T9.  A legal complaint was received from an attorney regarding a 63 year old white male patient who received an injection of FluShield vaccine on 01/04/2000.  Concomitant therapy included Cozaar and bumetanide for hypertension; Glucotrol for non-insulin-dependent diabetes; and Lipitor for hypercholesterolemia.  The patient's medical history also includes smoking, renal insufficiency, and asthma.  On 01/24/2000, the patient developed paresthesias in his legs with progressive weakness as well as tingling in his hands and facial area around his lips.  On 01/26/2000, he was hospitalized in the intensive care unit to rule out Guillian-Barre syndrome/acute inflammatory demyelinating polyneuropathy, rule out cervical myelopathy.  A CAT scan of the brain performed that day revealed mild cerebral atrophy with no evidence of tumor, intracranial hemorrhage, or infarct.  On 01/27/2000, the patient was transferred to the intensive care unit of a second hospital facility for plasmaphoresis.  An MRI of the brain performed that day was unremarkable; however, Guillian-Barre syndrome was not excluded.  While hospitalized, the patient received 6 courses of plasmaphoresis and made "slow but gradual" improvement of his numbness and weakness, with greater strength in his upper extremities than in his lower extremities.  He reportedly "responded well" to physical therapy.  On 02/10/2000, he was discharnged with a final diagnosis of Guillian-Barre syndrome to a rehabilitation facility for physical therapy.  He was subsequently discharged home with a walker.  Motor nerve conduction studies of the bilateral upper extremities and bilateral lower extremities performed on 06/12/2000 were "markedly abnormal" and demonstrated polyneuropathy with axonal and demyelinating features.  EMG of the right upper extremity was limited due to the patient's intolerance to the examination but revealed normal right biceps and right pronator teres muscles.  A physician's note dated 10/11/2000 indicated that the patient has permanent impairment of strength.  This report of a serious, labeled event is being submitted in a 15-day time frame as requested by FDA.  A 15-day follow up report received 08/14/2003 adds: Additional info was received from the plaintiff's attorney on 08/04/2003. A medical consultant reviewed the pt's hospital admissions and medical records sent to him by counsel covering the time period of 01/27/2000 through 12/06/2000 and provided additional laboratory results. He noted an MRI of the pt's spine on 01/27/2000 showed degenerative changes and small herniation at T8-T9. A legal complaint was received from an attorney regarding a 63-year-old male pt who received an injection of FluShield vaccine on 01/04/2000. Concomitant therapy included Cozaar (losartan potassium) and bumetanide for hypertention; Glucotrol (glipizide) for non-insulin-dependent diabetes; and Lipitor (atorvastatin) for hypercholesterolemia. The pt's medical history also includes smoking, renal insufficiency and asthma. On 01/24/2000, the pt developed paresthesias in his legs with progressive weakness as well as tingling in his hands and facial area around his lips. On 01/26/2000 he was hospitalized in the intensive care unit to rule out Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy, rule out cervical myelopathy. A CAT scan of the brain performed that day revealed mild cerebral atrophy with no evidence of tumor, intracranial hemorrhage, or infarct. On 01/27/2000 the pt was transferred to the intensive care unit of a second hospital facility for plasmaphoresis. An MRI of the brain performed that day was unremarkable; however, Guillain-Barre syndrome was not excluded. While hospitalized, the pt received 6 courses of plasmaphoresis and made "slow but gradual" improvement of his numbness and weakness, with greater strength in his upper extremities than in his lower extremities. He reportedly "responded well" to physical therapy. On 02/10/2000 he was discharged with a final diagnosis of Guillain-Barre syndrome to a rehabilitation facility for physical therapy. He was subsequently discharged home with a walker. Motor nerve conduction studies of the bilateral upper extremities and bilateral lower extremities performed on 06/12/2000 were "markedly abnormal" and demonstrated polyneuropathy with axonal and demyelinating features. EMG of the right upper extremity was limited due the the pt's intolerance to the examination but revealed normal right biceps and right pronator teres muscles. A physician's note dated 10/11/2000 indicated that the pt has permanent impairment of strength. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by FDA.  Medical records state weakness, hypotension. msv