Age: 34.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Alanine aminotransferase increased, Antinuclear antibody positive, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Hepatitis
Clinical narrative: The pt received his 3rd injection of Lymerix on 6/16/00. Blood analysis performed on 10/7/00 (113 days, post vax, the 3rd Lymerix) as part of an application for life insurance revealed elevated levels of SGOT-56 U/L and SGPT-109 U/L. "Multiple studies" were performed by the vaccine provider and a gastroenterologist. The only finding reported was a positive antinuclear antibody (ANA) titer of 1:64, with an homogenous pattern. A dx of autoimmune hepatitis was made. The autoimmune hepatitis persisted as of 8/4/01. Autoimmune hepatitis is considered "Medically Serious". The follow-up states that pt's medical history included caustic dermatitis present for at least "three to four years" due to solvent exposure, eczema, multiple skin novi, benign hypertrophy of the left massoter muscle, cropitus within joints NOS, left wrist injury resulting in carpal tunnel syndrome 1999, internal hemorrhoids 1991, chornic constipation, and lef tinguinal hernia 1994. Surgical history included left inguinal hernia repair, wisdom teeth removal, vasectomy, and carpal tunnel release. Concurrent medications included multivitamins with iron and Echinacea. Following the reported onset of autoimmune hepatitis, the vaccinee had sinusitis and lower respiratory tract infection, and a single benign retinal hemorrhage in the right eye. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. Blood analysis performed on 10/21/99 (121 days after the second injection of LYMErix) as part of an application for life insurance revealed normal levels of SGOT 29U/L and SGPT 37 U/L. However, alkaline phosphatase were elevated 120 U/L. Extensive diagnostic evaluation revealed antinuclear antibody titer of 1:640 with a homogenous pattern, normal white blood cell counts with elevated percentages of monocytes and eosinophils and an elevated LYME BIA with negative IgG and IgM western blot analyses. A diagnosis of autoimmune hepatitis was made, and the vaccinee was referred to a gastroenterologist. The gastroenterologist saw the pt on 12/26/2000. The vaccinee was asymtomatic. At the time of the consultation, the vaccinee was taking multivitamins with iron and Echinecea. The gastroenterologist's assessment was the following: "I discussed with the vaccinee abnormal liver enzymes can be from autoimmune hepatitis which would o along with an elevated antinuclear antibody. We discussed other possibilities such as Alpha 1 deficiency, iron overload from hemochromatosis or Wilson's disease. We sent blood work to look at these possibilities. We also scheduled him to have a liver bioopsy to look at degree of inflammation and damage in his liver. Once we have liver biopsy we will decide whether or not to treat his ANA positive hepatitis." The liver biopsy was performed on 02/24/01. Results were not provided to the vaccine provider, but the vaccinee reported that the biopsy showed "hepatitis." The gastroenterologist subsequently prescribed Imuran and prednisone. SGOT, SGPT, and alkaline phosphatase concentration were within the normal range on 06/19/01 and 07/24/01. A Mentoux tst for tuberculosis, administered 12/10/01, was negative after 72 hours. The most recent info was received from the vaccine provider on 01/04/02. He reported that the autoimmune hepatitis persisted as of 08/04/01. Autoimmune hepatitis is considered medically serious.