Age: 57.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Blindness, Dizziness, Eye discharge, Eye oedema, Headache
Clinical narrative: Information has been received from a physician concerning his 57 year old white wife, "in perfect health" with no known drug allergies and family history (mother) significant for rheumatic carditis, but no neurological or ophthalmological problems, who approximately August 2001, was vaccinated with 1 dose of hepatitis b vaccine recombinant (yeast). There was no local reaction. Concomitant therapy included low dose estrogens, conjugated (+) medroxyprogestrone acetate (Prempro), multivitamins (unspecified), vitamin b (unspecified), ascorbic acid, and vitamin e. On the afternoon of 09/03/01 the patient experienced sudden left upper superior quadrant vision loss. Her vision became cloudy on the left and she developed a sharp left frontpariental headache (x2) for a duration of 20 seconds, while shopping at the mall. There was no associated dizziness, nausea, or other symptoms. In addition there was no associated stress, trauma, toilet straining, or toxins. On approximately 09/04/01, she developed bilateral optic nerve swelling, "asymptomatic". No etiology other than (hepatitis b vaccine recombinant (yeast) has been found. Visual fields were examined by an ophthalmologist on 09/04/01. On 09/05/01, the patient experienced some transient visual loss in the right eye and right calf tenderness, for about an hour. Pulses and color were noted to be normal. "Sensory (fifth) left loss" for approximately 24 hours was reported. Fields were confirmed by confrontation and pin. On 09/06/01, the patient was seen by a neuro-retinologist. Fluorescein angiography was performed and reported to be "OK". That same day "neurologist fifth confirmed". In addition, an MRI was read as normal by two neuro-radiologist. On 09/07/01, the patient was seen by a neuro-retinologist. On 09/10/01, an immunologist and rheumatologist were consulted. The immunologist reportedly denied "reports of association (of vaccine) with optic neuropathy". It was reported that on 09/14/01, the patient had a "normal" mammogram and was also started on aspirin ("just because"), without symptoms. The aspirin was discontinued on 09/18/01. On 09/17/01, she was examined by a chiropractic neurologist. "Good neuro exam" was reported. No diagnosis was made and no treatment was prescribed. On 09/18/01, the patient was treated with acetazolamide (MSD) due to lightheadedness. "Spinal fluid and pressures" was noted for 09/20/01. On 09/24/01, the patient underwent further neurological consultation and follow-up with a retinologist. At the time of the report, the patient's sudden left upper superior quadrant vision loss and bilateral optic nerve swelling persisted. It was further noted that field defect and subjective complaints varied slightly and that the defect became worse after the patient sneezed. All studies of blood and optic nerve conduction were reported to be normal. Audiogram and acoustic reflex (unilateral only)  were also normal. At the time of the exam, there were no associated symptoms at all, including any headaches, pain, or fevers. The patient has never been seen by an internist. No complete exam was ever done. It was reported that she only wanted to be seen by "GYN". It was noted that she developed a severe 1st time allergic reaction to shitake mushrooms 5 weeks ago. She had an "uneventful trip (out of the country) (lyme) five weeks ago and about three weeks ago. Blood test negative. No clinical history. Upon internal review, sudden left upper superior quadrant vision loss, bilateral optic nerve swelling, transient visual loss of the right eye, left frontoparietal headache (x2), "sensory (fifth) left loss", lightheaded, and right calf tenderness were determined to be other important medical events. F/U states: information from a physician (the pt's husband) indicated that the pt "had negative complement, CH3, Ch50, sedimentation rate, Lyme...MRI, etc. He reported that his wife does not have optic neuritis but does have a bilateral optic nerve swelling and a unilateral visual field defect and intermittent clouding of vision with normal CSF pressures. No retinal edema was noted at the time of the exams. However, she did not have "clouding" at these times. He noted that his wife "does not have either the spinal fluid or MRI markers or clinical syndrome of MS at this time". He reported that she is taking aspirin and that no other therapy is planned at this time, her visual symptoms waiver but other subtle changes appear to be progressive. The follow-up info from a physician (the pt's husband) indicated that on 09/22/01 his wife experienced fluid in her ears. Not dizzy or stuffy. Review of symptoms negative. On 9/28/01 she expeirenced questionable visual floaters. ROS nevagive, retinolist confirmed. On 10/1/01 she was seen by a gynecologist for a pap smear. On 10/31/01 she was seen by a neurologist who noted optic disk pallor. On 11/8/01 she was seen by an immunologist. She plans to follow-up with two separate neuro-retinologists on 11/30/01 and in December 2001. The physician noted that his wife experienced variable subjective and constant field defect and subjective visual complaints. For instance, visual fefect may become worse after she sneezes or with fatigue. Follow-up info from the nurse retinologist indicated that he had examined the pt on 11/20/01. He had previously examined her on 9/7/01. Since the exam her vision has improved slightly. He reported that he had done a repeat visual field test on 11/20/01 and found that the vision in the pt's right eye was normal, however, the left eye showed an optic nerve swelling that will probably be permanent. The neuro retinologist was unable to indicate whether there was an associatioin between the hepatitis B vaccine and the left optic nerve swelling. Upon internal review, sudden left superior quadrant vision loss, bilateral optic nerve swelling, transient visual loss of the right eye, left frontoparietal headache, "sensory (fifth) left nerve loss," lightheaded, and right calf tenderness were determined to be other important medical events. The pt's husband (WAES01111379) developed chronic idiopathic demyelinating polyradiculoneuropathy following exposure to hepatitis B vaccine recombinant (lot 635813/1420K). Her husband felt that it was extremely improbable that anything other than the hepatitis B was the inciting factor for both he and his wife because they were both extremely healthy and infection free. Additional info has been requested.