Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Blood bilirubin increased, Jaundice, Leukocytosis
Clinical narrative: Information has been received from a physician concerning an 18 month old male who on 02/13/01 was vaccinated with a second dose of Hepatitis A virus vaccine inactivated. On 02/23/01, the patient developed jaundice and increased bilirubin. Upon internal review the patient's experience was determined to be an Other Important Medical Event. It was noted that the patients first dose of Hepatitis A virus vaccine  inactivated was administered on 05/18/00. Additional information has been requested. F/U On 3/8/01 the direct bilirubin was 2.9 and total bilirubin was 4.2. the pt had no other signs of viral infection. One week post vaccination he had abnormal labs. The pt continued to deteriorate and was seen in the transplant center 2 weeks ago and may possibly end up being transplanted. She added that the vaccine was given early to protect her son against hepatitis A. The physicians felt the jaundice and hyperbilirubinemia was caused by the hepatitis A vaccine. She also reported there was not explanation for his condition and she thinks that chances are his condition is not related in the vaccine since it is an inactivated vaccine. F/U another physician reported that the child did have a decreased WBC after the 1st dose of vaccine and he wondered if the viral stimulation irritated the liver. The pt was on therapy with Bactrim at the time of the decreased WBC count and he was not sure if the decreases in WBC was secondary to the Bactrim.The physician did not feel there was an association with the vaccine and the events but he did not know. A 15-day follow up report received 8/14/2003 adds: Info has been received from a physician concerning her 18 month old son born with biliary atresia who had surgery to correct the atresia at 3 weeks of age. Baseline levels of direct bilirubin was 0.3 and total bilirubin was 0.5. On 05/18/2000 the pt was vaccinated with hepatitis A virus vaccine inactivated (lot 632987/1753J). After the vaccination in May the pt's platelet and WBC count decreased. On 02/13/2001 the pt was vaccinated with a 2nd dose of hepatitis A virus vaccine inactivated (lot 637626/1645K) in the right deltoid. On 02/23/2001 the pt developed jaundice and increased bilirubin. Upon internal review the pt's experience was determined to be an Other Important Medical Event. On 03/08/2001 the direct bilirubin was 2.9 and total bilirubin was 4.2. The pt had not other signs of viral infection. One week post vaccination he had moderate viral count, elevated bilirubin, elevated WBC count and elevated alkaline phosphatase. The pt continued to deteriorate and was seen in the transplant center 2 weeks ago and may possibly end up being transplanted. The reporting physician added that the vaccine was given early to protect her son against hepatitis A. The physician initially felt the jaundice and hyperbilirubinemia was caused by the hepatitis A vaccine. She also reported that there was no explanation for his condition and she thinks that chances are his condition is not related to the vaccine, since it is an inactivated vaccine. Another physician, the pediatrician caring for the pt, reported that the child was born with biliary atresia and since it is a progressive disorder, it was known that the child would eventually require a liver transplant. The physician stated that the child's LFT's and bilirubin have varied over the course of his life but have not been normal. The child did have a decreased WBC after the 1st dose of vaccine and the physician wondered if the viral stimulation irritated the liver. The pt was on therapy with sulfamethoxazole (+) trimethoprim (Bactrium) at the time of the decreased WBC count and he was not sure if the decrease in WBC was secondary to the sulfamethoxazole (+) trimethoprim (Bactrim). The child's LFT's at that time did not increase. The physician did not feel there was an association with the vaccine and the events but he did not know. Additional info from the physician indicated that the child developed increased bili and liver enzymes approx 3 weeks (previously reported as one week post vaccination) after hepatitis A virus vaccine inactivated given on 02/13/2001. The pt was diagnosed with mononucleosis with unilateral laterothoracic exanthem. The physician noted that at this time he does not associate this event with the hepatitis A virus vaccine inactivated. The pt subsequently recovered from the event. No further details were provided. This is an amended report. The pediatrician's discussion of the liver transplant and LFT info has been added. Additional info received 8/12/03 from the pediatrician caring for the pt indicated the child is doing surprisingly well, and has been relatively stable for some time. The child has had a benign course without an increased frequency of infections. The physician reported that the pt's liver function tests were elevated but are stable for this pt. The pt's jaundice is not severe and his bilirubin levels have also remained slightly elevated, but are also stable for him. The physician indicated that the pt had been a candidate for a liver transplant because of his biliary atresia and that he is on the liver transplant list. No further info is available.