Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure decreased, Laboratory test abnormal, Malaise
Clinical narrative: From initial information received on 10/22/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 50 year old female patient received a dose of FLUZONE, lot number U1489AA, administered IM in the left deltoid on 10/8/04. Twelve days later, the patient died. The cause of death was not reported. A telephone call was placed to the reporter on 10/25/04 in order to obtain additional information. The physician reported that the patient was seen in the employee health department a few times in the past few months. She was seen on 8/16/04 with a complaint of not feeling herself. Her blood pressure at that time was 102/74. The patient was to follow up with her primary care physician. She was also seen on unspecified dates prior to vaccination with complaints of numbness in her legs, dizziness and lightheadedness. The physician also reported that the patient had complained to her co-workers approxiamtely one month ago that she was experiencing weakness and memory loss. As per the physician, there is very limited information for this case and the cause of death is unknown at this time. Additional information was received on 10/25/04 from the reporting physician. This case has been submitted to VAERS. The patient received the FLUZONE vaccination on 10/8/04 at 2:00 PM. Medical records and autopsy results were requested from the neurologist at the treating facility.  Follow up on 11/03/04 states: "From additional information received on 10/26/04 from a neurologist, it was reported that an autopsy was performed on this pt, however the results and the cause of death are still pending. The pt's hospital records were provided. The pt was hospitalized from 10/12/04 till 10/20/04.  She was admitted with a preliminary diagnosis of possible transverse myelitis. Her chief complaint was lower extremity weakness. She presented with an acute onset of thigh pain and tightness, as well as foot weakness and numbness. The pt first noticed upon awakening discomfort in her legs, which worsened thoughout the day and she subsequently developed numbness, especially of her feet and weakness of her feet, as well as an inability to walk. At 10:00AM, on the day prior to admission, she was unable to void. She presented to the hospital, where a post-void residual was noted to be one liter and a Foley catheter was placed. The pt was taken for an MRI of her spinal cord and the reports were normal. She was transferred to another hospital for further workup, as she was unable to walk. Prior to this, the pt was otherwise healthy. Motor examination revealed normal tone. Strength was intact in the upper extremities. Dorsiflexion was noted to be one on the right and absent on the left. Plantar flexion was absent bilaterally and tone was decreased in the lower extremities. There was decreased sensation to pinprick and temperature in both lower extremities up to the anus, with a pin level approximately at S3. There was no dysmetria on finger-nose-finger testing. Rapid alternating movements were intact. Gait could not be tested as the pt was unable to walk. During the HEENT examination, it was noted that the fundi were poorly visualized due to pupillary constriction, however the vessels appeared normal. There were no carotid bruits. Pupils were two millimeters, but reaction. An MRI of the cervical spine showed no evidence of abnormal spinal cord signal suggestive of transverse myelitis.  There were mild disc bulges at C5-C6, T6-T7, L3-L4 and L5-S1 without any mass effect. Cervical, thoracic and lumbar MRI was performed, which did not show any evidence of cord impingement. An MRI of the brain with and without contrast was done and showed some mild to moderate periventricular white matter changes consistent with small vessel ischemic disease, as well as multpile lacunarinfarctions in the thalami, left caudate head, and periventricular white matter.  Although this was most likely secondary to lacunar strokes, these areas of focal restricted diffusion and increased T2-weighted signal could be secondary to encephalitis (autoimmune or infectious). No intracranial bleed, mass effect, midline shift or hydrocephalus was identified. As the pt did not have any improvement in her numbness or weakness, she was given a trial of Solu-Medrol pulse dose of one gram every day for three days. She did not have any side effects in the first 24 hours, but was noted to become severely agitated and developed visual and auditory hallucinations by the second and third day of treatment and this was stopped after 3 days. The pt was started on risperidone one milligram two times a day for her acute psychosis, and after the steroids were discontinued, her mental status was noted to clear slowly, although she had difficulty orienting to place and time. She was consistently oriented to herself.   On the morning of 10/20/04, approximately before 12:00 noon, the pt developed acute convulsion with head turning to the right, eye deviation to the right, and rigidity followed by chronic movements of the upper extremities. It was unclear if the pt had oculogyric crisis possibly due to risperidone, which had been stopped two days prior or whether she was having a seizure. She was certainly at risk for a seizure due to the lesions in her brain. The pt had a brief lucid interval after the first episode of head turning and convulsions, but then subsequently became unresponsive and therefore CPR was started and standard ACLs protocol was followed.  After approximately 15 minutes of resuscitative efforts, the pt was unable to be resuscitated. The time of death was approximately 12:17PM. The discharge diagnosis was noted to be multiple lacunar infarcts in the thalami, left caudate head and periventricular white matter, as well as transverse myelitis, hypertension and hyperlipidemia. The preliminary diagnosis from the autopsy preliminary report included mild thyromegaly, soft and autolysed spleen, uterine leiomyomata. The neuropathological examination was pending fixation.