A pharmacist reported that a 47 year old female received Flu Shield on 11/6/02. Medical history includes a mental handicap. Subsequent to immunization, the pt experienced neurological symptoms. She was described as "less responsive" with "loss of ability to move her lower extremities." The pt was taken to an acute care facility (where the pharmacist is employed) and then transferred to a medical center. Tests (not identified) were performed with negative results. As of the last report received from the hospital, the pt was unable to move her legs.  A 15-day follow up report received 02/19/2003 adds: Medical history includes 'mild' mental retardation, epilepsy and obsessive compulsive disorder. Concomitant medication included fluvoxamine, valproate semisodium (Depakote), acetaminophen (Tylenol), vitamin C (Centrum Vitamin C), multivitamins with minerals, and Falvit (calcium/vitamins). On 11/6/2002, the pt was brought to the ER. A day or two prior, she was noted to be increasingly lethargic, with a rapid heartrate and a distinct change in her mental status. On 11/8/2002, she was admitted to the hospital, started on intravenous fluids and maintained on 'Fluxomine'. Initial Depakote levels were 139. She was diagnosed with Depakote toxicity and Depakote was withheld. Depakote levels returned to normal though the pt's mental status remained unchanged. A neurology consultation was obtained and she was treated with Atenolol for a persistent increased heart rate. The pt developed a fever. A diagnosis of encephalitis was suspected. A lumbar puncture was performed (unremarkable) and acyclovir sodium (Acyclovir) was started. A central line was placed to facilitate intravenous access of medications. The pt's condition remained essentially unchanged, with persistent restlessness, confusion, change in mental status, intermittent tachycardia, and intermittent fever. No definite neurological diagnosis was made. Discharge medications included ceftazidime (Fortaz), hydroxyzine hydrochloride (Atarax), lorazepam (Ativan), valproate semisodium (Depakote) and atenolol (Tanormin). On 11/26/2002, the pt was transferred to a University Medical Center for further neurological evaluation. At the University Medical Center she was diagnosed with fever of unknown origin, possible immunodeficiency, anemia and hypertension. Laboratory tests and procedures include the following: On 12/2/2002, a Computerized Tomogram of chest, abdomen and pelvis revealed nodule opacity in the apex of the right lung, less than 1 mm; noncancerous appearing right middle lobe nodule, borderline, pretracheal node, simple left renal cyst. A chest X-ray also noted nodular density. On 12/28/2002, blood culture results revealed 'MRSA grew and was thought to be nosocomial'. She was treated with vancomycin hydrochloride (Vancomycin) for 14 days. A Nuclear Medicine Bone Scan was normal though 'slight increase turnover in her right shoulder'. CD4 lymphocytes were 173 (abnormal). A CDS lymphocytes were 108 and CD3 were 320. A blood Immunoglobulin G was 1932 (slightly high). A Immunodeficiency Cell Marker Study resulted in abnormal findings as follows: 60% mature T cells, 12% natural killer cells, 22% mature B cells, 22% mixture of mature and immature B cells. D cell population had a CD4-CD8 ratio or 4:1. CD4 helper cells consist of 60% hemoxy cells and 40% naive cells. CD8 cells were classified according to their CD28 markers. The B cell population was classified according to HR8-DR and the CD19 markers 8-9% of the B cells had surface immunoglobulins and was noted to have decreased expression of IgM and IgD expression. This was variable. It could possibly indicate immunodeficiency such as common variable hypogammaglobulinemia, although this is not clear. Additional tests were performed with negative findings (see source document for details). The pt's fever was noted to be a 'mystery even after every test available to us was done'. She was treated with vancomycin hydrochloride, co-trimoxazole (Bactrin) and gancioclovir sodium with no change in temperature. She was treated with suppression therapy with acetaminophen (Tylenol) and then naproxen sodium. She improved though continued to have 'minor' fevers. The pt's mental status never changed. She was never alert or oriented. She never spoke in a meaningful way or responded in a meaningful way to any verbal commands or noxious stimuli. The pt was noted to be anemic (iatrogenic anemia) on admission as a result of continuous blood draws for a month and a half. The blood draws were reduced; she stabilized and improved. During the second hospitalization, the pt developed hypertension. She was treated with metoprolol fumarate and was controlled well. The CD4 and CD8 counts were normal on January 22, 2003 and Bactrin for PCP prophylaxis was discontinued. The pt received a PEG tube for tube feeds, on January 23, 2003 without any complications. She was discharged on 01/28/2003 in stable condition, to a long term care facility. On follow-up, a physician reported 'we have no hard evidence to suspect that the immunization had anything to do with her rather bizarre neurological problem'.