Age: 70.0
Sex: M
Vaccine: TD
Symptoms: Calculus ureteric, Cardiac arrest, Cholelithiasis, Diarrhoea, Gallbladder disorder
Clinical narrative: This subject is a 70 year old male, who was admitted to the hospital due to abdominal pain while enrolled in a study. The last dose prior to the event was given on 5/28/04. The patient received either a foreign Td vaccine or Td vaccine (control product) (lot number not reported). The subject developed abdominal pain 30 days post-immunization and was admitted to the hospital the same day. He had a seven day history of epigastric and right upper quadrant pain and a two week history of weakness, nausea, vomiting, weight loss, diarrhea and anorexia. The initial CT scan done showed ascites and multiple lesions consistent with carcinomatosis. A cirrhotic liver was also noted, a thickened gall bladder, no diluted ducts and right hydronephrosis. Reportedly, the etiology of the cirrhosis was likely due to the hepatitis C. A chest x-rays showed an elevated right hemi-diaphragm and bilateral pleural effusion. Initial labs showed an abnormal ALT of 102, bilirubin of 1.8, alkaline phosphatase 168. Treatment given was not reported. He was discharged from the hospital three days later. The subject's recovery status was unknown at the time of this report. The abdominal pain was reported by the investigator as unrelated to the study vaccine. List of additional information received and available in source file: Fax covers, initial reporting form, history and physical, physical examination, lab reports, IND SAE fax reports and fax confirmation (12 pages). From additional information received on 7/7/04 it was reported that the patient died on 7/2/04. Patient developed abdominal pain on 6/24/04 changing the latency to 27 days post immunization. He was diagnosed with ruptured hepatoma/hepatocellular carcinoma, ascites, carcinomatosis, Hepatitis C with cirrhosis of the liver and hydronephrosis. An ultrasound guided paracentesis which showed frank blood in the ascetic fluid compatible with a possible hematoma with probable rupture associated with a hemo-peritoneum. The subject underwent an MRI of the abdomen which did confirm ruptured hepatoma/hepatocellular carcinoma. The subject was discharged home with hospice care to follow up as an outpatient. The following medications were prescribed on discharge: Vicodin 2 tables orally every four hours for a pain scale less than 5.10. Use morphine sulfate liquid for breakthrough pain. A stool softener of Colace to be taken twice a day was prescribed for constipation. The ruptured hepatoma/hepatocellular carcinoma, ascites, carcinomatosis, Hepatitis C with cirrhosis of the liver, hydronephrosis and death was reported by the investigator as unrelated to the study vaccine. The etiology of the cirrhosis was likely due to the hepatitis C. The question remains of the cause of the hepatic metastases. A CEA, PSA, and AFP will be checked. A phone call was made to the IR department for paracentesis for both diagnostic and therapeutic procedure. If this patient has symptoms, spironolactone 12.5mg daily should be started. No autopsy was done. Pt died at home.  Nurse follow up on 10/13/04 states: "Liver cancer, Hepatitis C, Cardiovascular arrest, ruptured hepatoma."