Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Gait disturbance, Gastrooesophageal reflux disease, Gaze palsy, Groin pain
Clinical narrative: From initial information received on 09Feb05 from the pt's wife regarding an adverse event occurring, it was reported that an 81 yr old male pt received a dose of Fluzone SV 2004-2005USP, lot U1504AA, with the expiration date of 30Jun05, admin in the left deltoid on 26Oct04 at a pharmacy clinic. The route of admin was not reported. Five days later, the pt experienced severe pain in his legs and groin area. Subsequently, the pt gradually spread over his entire body. In addition, the pt developed nausea and an equilibrium disorder. Per the reporter, the pt now comes and goes and is less severe. The pt was seen by a general practitioner, then referred to a neurologist. Reportedly, the pt received a flu vaccine annually. He did not recover from these events. From additional information received on 10Feb05 the reporter forwarded the report she submitted online which included the information that the pt had confusion and was unable to walk and was losing weight. He also had a chest x-ray which was normal and an MRI and EMG, results not reported. From additional information received on 22Jun05 and 27Jun05 from the pt's wife, copies of clinical notes from visits with physicians were provided. The pt was seen by a physician on 24Jan05 with a complaint of generalized weakness. He had received the influenza vaccine on 26Oct04 and about one week later felt dumpy. He experienced pain and weakness in his lower extremities. In the mornings he has felt sick to his stomach. He has decreased ambition, feels pooped out, has significant postural lightheadedness and has been more confused since Christmas.  The pt was seen by a physician on 24Jan05 with a complaint of generalized weakness. He had received the influenza vaccine on 26Oct04 and about one week later felt dumpy. He experienced pain and weakness in his lower extremities. In the mornings he has felt sick to his stomach. He has decreased ambition, feels pooped out, has significant postural lightheadedness and has been more confused since Christmas. The pt describes his mood as being down and as having a poor appetite. The pt has difficulties with sleep and fatigue and some difficulties with balance which is associated with postural lightheadedness. The pt reports nausea and gastroesophageal reflux disease, nocturia and feeling depressed and anxious. A neurological examination was unremarkable except for some end gaze nystagmus, which was more prominent when the pt looked to the right. The pt was seen again by a physician on 16Feb05 and reported that he is feeling about 50% better compared to the beginning of the events. At that time he still had pain in his muscles, mostly the leg muscles and the buttock area. He cannot walk for a long time because of the fatigue and muscle aches. At times when he has lost his balance, he has fallen. He denied fever, chills, dysuria and diarrhea. He had complained of headaches for approx one week and has had some constipation. Additionally, he reported that his joints were achy in the left, thigh and buttock area. Physical examination was unremarkable and the pt was fully alert and oriented in no apparent distress. A neurological  examination was without lateralizing signs or signs of meningeal irritation. Per an infectious disease physician, the events could be related to the vaccine or the pt might have acquired a viral illness with viral labyrinthitis. The pt is gradually improving and the physician recommended continued observation of the pt's symptoms. In addition, due to the family history of lupus, it was recommended to investigate the possibility of connective tissue disease. As of Feb 2005, the pt was gaining strength and seems to be on the mend. This incident was reported on 10Jan05. The pt's wife had also informed the local dept of health. At the time of this report, the pt has not recovered from these events. Based upon medical judgement this case is being upgraded to serious.