Information has been received from a physician and a registered nurse concerning a 38 month old identical twin female with no pertinent medical history, except occasional upper respiratory infections and ear infections who on 1/3/01 and 1/16/03 was vaccinated with a first and second dose of hepatitis A virus vaccine inactivated (lot # not provided). There were no concomitant medications. There was no illness at the time of vaccination. On 3/13/03 the patient was seen by the physician for vomiting and was treated for gastroenteritis. On 4/14/03 she returned to the office with jaundice of her eyes. She was sent for lab work, which revealed elevated LFT's. The hepatitis panels were negative at that time. Subsequently, the patient was feeling better, but her labs were not improving. On 4/30/03 the patient was seen by a gastroenterologist who repeated the labs and found that the patient was positive for hepatitis A. An abdominal ultrasound was normal. The registered nurse noted that the physician felt that the first set of hepatitis panels may have been done too early. She was not aware of any treatment that the child had received. It was reported that no one else in the patient's family had been sick. The patient's mother had reported that the only change that had occurred was that they were remodeling their kitchen and were, therefore, eating out a lot. Subsequently, the patient has recovered completely. On 7/15/03 it was reported that the nurse had seen the patient recently and she looks and feels great. No product quality complaint was involved. Upon internal review, gastroenteritis and hepatitis A were determined to be other important medical events (OMIC). Additional information has been requested.  Follow up on 09/12/2003: "Information has been received from a physician and an RN concerning a 38 month old Armenian identical twin female, delivered by cesarean section, with no known allergies, up to date immunizations, no hospitalizations or surguries, and a history of occasional upper respiratory infections, ear infections and neonatal jaundice.  There is a positive family history for heart attack, eczema, thyroid disease, diabetes mellitus, ulcers, gallstones, ulcerative colitis and cancer.  There is no family history of hepatitis B or C and no history of liver disease.  On 01/03/2002 (previously reported as 01/03/2001) and 01/16/2003 the patient was vaccinated IM in the right arm with a first and second dose of hepatitis A virus vaccine inactivated (Lot # not reported).  There were no concomitant medications.  There was no illness at the time of vaccination.  On 03/13/2003 the patient was seen by the physician for vomiting and diarrhea that was diagnosed as gastroenteritis.  On 04/14/2003 she retured to the office with jaudince of her eyes (also described as 'because the whites of her eyes were yellow').  She was sent for lab work, which revealed elevated LFT's.  The hepatitis panels were negative at that time.  On 04/15/2003 laboratory data results included: a CMV IgG, and IgM were nevative; Hepatitis B core antibody IgM negative.  EBV PCR serology negative; CBC is entirely within normal limits except for increased atypical lymphs at 14%; Prothrombin time was 25, ALT 538, alkalilne phosphatase 224, CRP 0.7, AST 942, albumin 4.  Total bilirubin 4.6, conjugated bilirubin 2, glucose 131, Hepatitis A antibody IgM negative, ammonia 25.  Subsequently, the patient was feeling better, but her labs were not improving.  An abdominal ultrasound was normal.  On 04/25/2003 prothrombin time fell to 17, albumin continued to be normal at 4.6, ALT 480, AST 866, alkaline phosphatase 223, total bilirubin 5.4, conjugated 2.1.  It was also reported that no one else in the patient's family had been sick.  The patient's mother had reported that the only change that occured was that they were remodeling their kitchen and were, therefore, eating out a lot.  The registered nurse noted that the physician felt that the first set of hepatitis panels may have been done too early.  She was not aware of any treatment that the child had received.  On 05/05/2003 the patient was seen by a gastroentrologist for evaluation of transaminasemia and hyperbilirubinemia.  The patient was also having symptoms of decreased appetite and tiredness, some irritability, perhaps some nausea and two episodes of vomiting subsequent to the initial finding of jaundice and icterus in the past three weeks.  The mother had not noted any increased gum bleeds, nose bleeds or easy bruisability.  There had been no pruritus or fever.  She had noticed darkened urine.  There had been looser stools recently than in the past.  The patient had no exposure to ground water and had not traveled outside the state.  The patient was not exposed to anyone with hepatitis.  Neither the mother nor the father have had hepatitis.  The mother has had a blood transfusion in the past.  Current medications include chewable multivitamins (POLY-VI-FLOR), one QD.  There have been no herbal medications taken.  On physican exam the skin was slightly jaundiced. The gastroenterologist's impression was that of a child with hypertransaminasemia and hyperbilirubinemia with a negative work-up to date.  It was noted that it was worrisome that the patient had an elevated prothrombin time meaning that the synthetic activity of her liver may be impaired by what appeared to be an infectious hepatitis.  It was also noted that it was possible that her antibody response had not "kicked in yet" with the CMV, or EBV PCR.  It was also possible that she did not respond to the hepatitis A or B vaccines.  The gastroenterologist planned to recheck the patient's comprehensive metabolic panel, GGT, ammonia, CMV panel, EBV PCR, total antibody, hepatitis C total antibody, hepatitis B surface antigen, hepatitis B surface antibody and hepatitis B core antibody.  If that work-up was negative she would then need to look into unusual etiologies such as alfa I antitrypsin deficiency, hemachromatoses, autoimmune hepatitis, and Wilson's diesease and if her prothrombin time continued to be elevated she would like to give the patient Vitamin K 5 mg QD for a week and then repeat the prothrombin tme and see if she was responsive to Vitamin K supplementation.  It was noted that the patient "actually looks very good and very healthy".  The physician told the mother that she really suspected that she had a simple infectious case of this transaminasemia and that it would most likely be self-resolving.  Nutritionally, the patient continued to do well and was maintaining her hydration status, therefore, hospitalization was not necessary.  On 05/05/2003 additional lab results included: AST 672, ALT 319, GGT 237, albumin 4.7, total bilirubin 4.7, alk. phos 193, ammonia 20, EBV and CMV panels negative, Hepatitis A antibody positive, hepatitis B surface antigen and hepatitis C antibody negative.  On 05/19/2003 additional lab results included: prothrombin time normalized to 13.8.  It was noted that the patient had been given a one week course of Vitamin K, 2.5mg QD for elevated prothrombin time of 16.8.  On 05/23/2003 the patient was seen again by the gastroenterologist for follow up of her hepatitis A.  The mother reported to the physician that her daughter's energy level was back to normal and that her apptetie was better but still not back to normal.  She was having 2-3 bowel movements a day and no complaints of nausea or vomiting.  The mother noted that her jaundice was resolved.  Other aspects of the review of systems were noncontributory.  The physician's impression was that of a child with hepatitis A which was resolving.  Her liver enzymes had not normalized but her prothrombin time had, indicating good synthetic function.  She was gaining weight now and obviusly her bilirubin was normalizing since she was no longer jaundiced.  The mother was asked to check a comprehensive metabolic panel and prothrombin time in three weeks, just to make sure everything continued to normalize or remained normal.  Subsequently, the patient has recovered completely.  On 07/15/2003 it was reported that the nurse had seen the patient recently and "she looks and feels great".  No product quality complaint was involved.  Upon internal review, gastroenteritis and hepatitis A were determined to be other important medical events (OMIC).  Additional information has been requested."