Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy liver abnormal, Biopsy skin abnormal, Blood albumin normal, Blood alkaline phosphatase increased, Blood bilirubin normal
Clinical narrative: Information has been received from a health professional concerning an adult female who on an unspecified date was vaccinated with a dose of Zostavax. Post vaccination, the patient developed tumors on her liver which were confirmed by ultrasound. It was noted that prior to vaccination, the patient was healthy. The patient was referred to a physician for follow-up and another ultrasound was performed. It was found that the tumors disappeared, "are in remission." A product quality complaint was not involved. Additional information has been requested. Information has been received from a health profesisonal concerning a 71 year old female with no known allergies who on an unspecified date in October 2006 was vaccinated with a dose of ZOSTAVAX. Post vaccination, the patient developed tumors on her liver which were confirmed by ultrasound. It was noted that prior to vaccination, the patient was healthy. The patient was referred to a physican for follow-up and another ultrasound was performed. It was found that the tumors disappeared, "arein remission." A product quality complaint was not involved. Additional information, including medical records, has been received from the health profesional. On 05-JAN-2007, the patient was seen in consultation for abnormal liver tests. It was noted at that time that the patient was in her usual state of health until October 2006, when she received a dose of ZOSTAVAX. One week later, she developed a rash on the chest which lasted initially one month and came back after a couple of weeks. She was seen by an infectious disease specialist. Her workup was negative for chickenpox and she was referred to a dermatologist. The dermatologist biopsied the lesions and the pathology came back as consistent with Grover's Disease. She was treated with cortisone cream, and the rash has almost subsided. However, she was noted to have abnormal liver tests. her alkaline phosphatase was 715, bilirubin 1.1, albumin 4.8, AST 82, ALT 114. Her cell count was normal. Hepatitis serologies were also noncontributory. ANA was negative. CMV and EBV serologies were noncontributory. An abdominal ultrasound on 29-DEC-2006 showed heterogenous liver and a CT scan showed numerous low-attenuating, diffusely scattered, enhancing hepatic lesions. Differential considerations could include metastic disease, granulomatous disease, infectious process, or lymphoma. Given the history of shingles, hepatic involvement by varicella zoster virus would also be in the differential. The patient continued to feel very weak without any appetite. She has some diarrhea, nausea, and weakness. She also stated that she had intermittent low-grade fever. She has a history of TEGRETOL hepatitis in the 1980s and also became jaundiced after being treated with QUINAGLUTE in 1976. She received a re-challenge with recurrence of her symptoms. She denied any history of recent travel and she had no risk factors for viral hepatitis. Other past medical history was noted to include hypercholesterolemia, gastroesophageal reflux disease, chronic joint pain, a recent history of chickenpox, history of cardiax arrhythmia, hypothyroidism, and a history of depression. Past surgical history included appendectomy, cholecystectomy, eye surgery for detached retina, hysterectomy, hemorrhoidectomy, and spinal fusion. Concomitant medications were noted to include SYNTHROID, PROZAC, aspirin, ezetimibe, NEXIUM, calcium, glucosamine, magnesium, atenolol, trazadone, ACTONEL, and estrogens. The assessment was multiple liver lesions, hard to explain from the vaccination. Liver tests and clinical picture not suggestive for varicella hepatitis which usually is fatal. A 12-JAN-2007 pathology report from a right liver mass showed mild portal and lobular inflammation and no dysplasia or malignancy was identified. It was also negative for herpes simplex virus. A 12-JAN-2007 fine needle aspiration of the liver showed benign hepatocytes, steatosis, and mild chronic inflammation. An MRI of the abdomen performed on 15-FEB-2007 showed a near-complete resolution of numerous hepatic lesions, with only two small lesions in the right  lobe remaining. The rapid change suggested inflammatory etiology. On 20-FEB-2007, the patient was seen by a hepatologist. It was noted that the patient felt completely better and the MRI was repeated which showed resolution of the nodules. The assessment was acute hepatitis of unknown etiology after ZOSTAVAX with complete resolution of the nodules  on MRI with follow-up MRI and decreasing liver function tests. A liver biopsy report from 26-APR-2007 noted the following clinical information; patient was in health until "August 2006" when she received ZOSTAVAX. She developed a skin rash approximately one week later, and a skin biopsy was thought to represent Grover's disease. Soon after she developed markedly elevated alkaline phosphatase and moderately elevated AST and ALT. An MRI scan demonstrated low attentuation lesions. A biopsy of the liver in January 2007 demonstrated a mixed pattern of hepatitis/possible chalongitis. There was no histologic findings to explain the presence of mass lesions. Subsequently, the patient's liver by chemical studies returned to normal and she felt better. Approximately two months later, however, she became fatigued and repeat liver tests demonstrate an elevated alkaline phosphatase, AST, and ALT, and a repeat imaging study failed to demonstrate any mass lesions. it was noted that there was less inflammation in the portal areas and in the lobules than was seen in the patient's previous biopsy. The findings most likely represented an atypical immune reaction to the vaccine or another drug or herbal product. A repeat of autoimmune and viral markers may also be helplful in order to exclude evolving viral or autoimmune hepatitis or cholangitis. On 03-MAY-2007, an immunoperoxidase stain for herpes simplex virus was negative. An immunoperoxidase stain for CD68 highlighted numerous Kupffer cells, and occassional aggregates within portal tracts. A stain for fungal organism was negative, a gram stain was negative and a silver stain for spirochetes was negative. The diagnosis was unchanged. See laboratory section for all relevant diagnostic tests. No further information is expected.