Age: 58.0
Sex: M
Vaccine: HEPAB
Symptoms: Demyelination, Difficulty in walking, Diplopia, Guillain-Barre syndrome, Hemiparesis
Clinical narrative: This report describes the occurrence of chronic inflammatory demyelinating polyneuropathy in a male between 65 and 70 years of age who was vaccinated with hep A inactivated and hep B recombinant vaccine (Twinrix) for prophylaxis. The subject's medical histroy, concurrent conditions, and concurrent medications were unknown. The subject received his third injection of Twinrix on 6/24/02. While traveling approximately four months post-immunization, between mid-October and mid-November 2002, he was reportedly told that he had developed Guillain-Barré syndrome. He returned to home, where a neurologist made a diagnosis of CIDP and prescribed prednisone. His physician considered  Twinrix to be the cause of the CIDP. As of 11/19/02, the CIDP persisted, but had improved. This report of CIDP is considered medically serious (OMIC). The follow up received on 1/8/03 states that the subject's medical history included hypercholasterolemia and gastroesophageal reflux disorder. Concurrent medications included Zocor and Prevacid. The subject received injections of Twinrix on 3/27/02, 4/26/02, and 6/24/02; lot numbers were not provided. The third injection was administered three months after the first injection, rather than the recommended interval of six months. The subject also received a booster injection of tetanus and diphtheria toxoids (manuf unk) on 3/27/02. The subject left "shortly after" receiving the third injection of Twinrix. While traveling approximately four months post-immunization, he was reportedly told that he had developed Guillain-Barre syndrome. He returned home, where he was evaluated by a neurologist on 10/25/02. The subject presented with "weight loss, dyaesthesia and weakness most pronounced in the left lower extremity." The subject reported that "shortly" after receiving the third injection of Twinrix, he began to exeprience weight loss and tingling in his feet and fingers. On a separate form, the neurologist recorded the onset date as 6/24/02. The subject reported that "over a three month period he has had a 15 pound unepected weight loss which has now stabilized. He was previously taking Zocor but this was discontinued three weeks prior. He had been on it for the last two years. Rougly one month prior he noted a left foot drop. He has had some difficulty with walking. Directed neurlogical examination revealed three beats of nystagmus to lateral gaze bilaterally with slight horizontal diplopia. Motor teting revealed normal strength, except in the left triceps, left flexor carpi ulneris, bilateral abductor pollicis brevis, bilateral first corsal interossous, bilateral abductor digiti stimuli, bilateral first dorsal interosaous musculaturo, bialteral opponens pollicis, left tibiallis anterior, left extensor hallucis longue, left ribialis posterior, and left peroneus longus. The weakest muscle group, the left flexor carpi ulneris, was rated "4 to 4-/5." The physician also noted "A stocking-glove hyposthesia to sharp and cold sense was detected. Sensation was intact to vibration. DTRs were 2 at the biceps, 1+ at the right tricep and 2 at the left tricep, 1+ at the brachioradialis on the left and trace on the right, absent at the finger flexors, 2 at the left tricep, 1+ at the brachioradialis on the left and trace on the right, absent at the finger flexors, 2 at the patellae and 2+ at the ankles. Toes were downgoing bilaterally." Nerve conduction studies yielded findings "suggestive of a low-grade motor-sensory polyneuropathy with significant demyelinative components." The rest of the diagnostic evaluation was within the reference ranges. No nerve biopsy was performed. The neurologist stated, "When evaluating both his neurologic exam and neurophysiologic findings, one would wonder about the possibility of a vaccine-related peripheral neuropathic response with demyelinative elements." The neurologist subsequently made a diagnosis of CIDP and prescirbed prednisone. He considered Twinrix to be the cause of the CIDP. The subject returend to the neurologist on 12/9/02. "He continues to complain of a diffuse sense of fatigue. There is no specific muscle weakness that he is currently appreciating. He has also noted neck pain over the left side of the neck and into the shoulder over the last one week. He notes some occasinal tingling dysesthesia in the fingers. This has not been significantly troublesome to him. Examination today reveals normal strength at 5/5 with the exception of the abductor digiti minimi at 4+/5 bilaterally. The remainder of the hand intrinsic muscle strength is normal at 5/5. Triceps is completely normal as well. He has been off his prednisone for two weeks. At the present time I feelt aht he has made continued progress. he was seen by another phsyician and a follow up nerve conduction study was somewhat improved as well. He will continue his vitamins and exercise." The most recent info was received on 1/8/02. The neurologist indicated that the CIDP was unresolved.