Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysaesthesia, Electromyogram abnormal, Malaise, Monoclonal gammopathy, Nerve conduction studies abnormal
Clinical narrative: Initial report was received on 05 January 2012 from a health care professional, at which time this case was assessed as non-serious listed. Based upon follow-up information received on 24 February 2012 from a health care professional, it was determined this case now meets seriousness criteria (hospitalization) and this case has been upgraded from non-serious to serious. This narrative includes information reported on both dates. A 76-year-old female patient had received an intramuscular injection in the left arm of FLUZONE HIGH-DOSE, sanofi pasteur Inc. lot number UH468A on 15 October 2011. On 09 November 2011, the patient complained of pain and weakness. The patient felt ill the Sunday evening before and had been fine that Sunday AM. The next morning she noticed significant weakness, went to see her physician and felt that there was a sinus infection. By 09 November 2011 she was admitted to the emergency department (ED). The patient had not been ill before 06 November 2011. The patient went sent to short term rehabilitation (STR) on 21 November 2011 with slow improvement. Upon exam, the patient had "some mild dysesthesias in her feet but no significant weakness since CTX for her lymphoma." The patient's "motor was 4+ in the lower extremities (LE's) distal - proximal." "There was a dec. pp to the ankles and the hands distally. L28 is 3 seconds in the left ankles and absent in the left ankle and knee." The patient was able to bear weight with assistance but was ataxic. Deep tendon reflexes (DTR's) were absent in the ankles and knees and trace in biceps. The impression was that there was a severe sensorimotor polyneuropathy, demyelinating, with evidence of some minimal axon loss in the right tibial anterior and medial gastrocnemius that may be neuropathy related or involved with an additional L5 radiculopathy. The physician's suspicion was that the patient had an acute demyelinating neuropathy superimposed on a probable long standing monoclonal gammopathy. The overall prognosis was good with continued physical therapy (PT). The physician recommended against further flu shots. The results of the electromyogram (EMG) and nerve conduction velocity test (NCV) are as follows: Evaluation of the left peroneal motor and right peroneal motor nerves showed prolonged distal onset latency, reduced amplitude, decreased conduction velocity (B Fib-Ankle) and decreased conduction velocity (Poplt-b Fib). The left tibial motor nerve showed prolonged distal onset latency, reduced amplitude, and decreased conduction velocity (knee-Ankle). The right tibial motor nerve showed no response (ankle) and no response (knee). The right ulnar motor nerve showed prolonged distal, onset latency, reduced amplitude, decreased conduction velocity (B Elbow-Wrist) and decreased conduction velocity (A Elbow-B Elbow). The left sural anti sensory and the right sural anti sensory nerves showed no response (calf), no response (site 2) and no response (site 3). F wave studies indication that the left prolonged latency (40.00ms). The remaining F wave has no response. The right ulnar F wave has prolonged latency (40.00ms). The remaining F wave latencies were within normal limits. Posterior tibial (S1) H-reflex studies indication that the left tibial H-reflex has prolonged latency (50.22ms). The right tibial H-reflex has abnormal no response. The EMG demonstrated minimal findings of uncompensated axon loss, primarily in the right Tib. Ant, an medical gastrocnemius with a prominent amount of polyphasic potentials and relatively good recruitment. The patient was followed for Non-Hodgkin's Lymphoma (NHL) every 4 months since August 2008. The patient also has a history of hypersplenism. It was unknown if the patient took any concomitant medications. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.