Information has been received regarding a case in litigation concerning a male who was vaccinated with a dose of hepatitis A virus vaccine inactivated. In 2001, the patient received the vaccination due to a work assignment outside the country. From November 2001 to January 2002, the patient became seriously ill. Medical tests determined that he had contracted hepatitis A and had suffered severe liver damage. At the time of the report, the patient continued to suffer symptoms of the disease and has been unable to work. The patient claimed the vaccine he received failed to protect him from the debilitating liver disease. It was reported that hepatitis A virus vaccine inactivated pre-filled syringes were recalled after 5/29/01. The patient was notified of the recall in December 2001; however the patient did not return from his work assignment until more than one month later. Upon internal review, hepatitis A and severe liver damage were considered to be other important medical events. Additional information has been requested.  Received on 06/03/2003: "Follow up information indicated that the patient left the country on 11/03/2001 and returned to the country on 01/28/2002.  It was noted that the patient became "very ill while he was away".  It was indicated that he "began experiencing symptoms of hepatitis A in early December 2001.  He experienced fatigue, and had no appetite, frequently vomited after eating and his skin appeard slightly yellow".  The patient treated his symptoms with over the counter medications, "believing that he was suffering from dysentery".  On 03/10/2002, the patient was again assigned to work outside of the country.  The patient continued to experience extreme illness while he was out of the country and sought medical attention once he returned "home" in May 2002.  Blood tests, urine tests, and chest x-rays were ordered, and the patient was diagnosed with hepatitis A and it was noted that his liver was severely damaged as a result.  It was noted that as a result of the vaccine's failure, the patient "contracted hepatitis A and became ill in December 2001 and continues to experience symptoms presently", as of 05/20/2003.  Upon internal review, hepatitis A and severe liver damage were considered to be other important medical events. Additional information has been requested.  (OMIC) Follow up on 10/28/2003: "Follow up information received from medical records indicated that the patient presented to the physician's office on 09/09/2002 with a history of general malaise, pains, fatigue, and some dark urine for approximately 10-11 months.  According to the patient, he out of the country in 12/2001 due to job related issues.  Prior to his travel, he was vaccinated with a dose of hepatitis A virus vaccine inactivated and also received malaria prophylaxis.  While out of the country, the patient started feeling sick and mostly his symptoms were described as some fevers, sweats, chills, dark urine, yellow stools, depression, generalized fatigue, not feeling well, and malaise.  The patient's symptoms have been persistent since then without any significant improvement.  Since the patient has returned to the country "three to four months ago", he has been persistently short of breath with fatigue and cough.  He has some abdominal pains, diarrhea, yellow stool, dark urine and stiffness in his joints.  The patient had a significant work up done by his primary care physician including hepatitis B and C serolgies, which were negative.  It was noted that the patient was vaccinated with a first and second dose of hepatitis b vaccine (manufacturer unknown).  His hepatitis C antibody was negative.  Hepatitis A IgM was negative but IgG was positive.  The patient was found to have increased LFT's in 100 range, below 200 range, and also was found to have lymphocytosis on CBC.  His chest x-ray was negative.  There is no record of blood cultures drawn at that time.  The patient had a clarithromycin (Biaxin) tiral and he apparently did not resond.  Also, the patient had an ultrasound done in June of his right upper quadrant, which showed some fatty liver, otherwise no significant findings.  He had an EGD done and he also had a colonoscopy done.  All were negative.  His stool studies were negative for ova and parasites and his CD also was done.  The patient does not have any significant headaches, no visual changes, but has very generalized malaise.  He still had feelings of fevers, and some chills and sweats.  The patient has shortness of breath and persistent cough, mostly dry.  He has no sore throat. The patient has diffuse abdominal pain.  He has yellow stool and dark urine, stiffness in his joints, and tremors in his hands.  The patient also reported that he had PPD placed in the past, which was negative.  The physician indicated that the patient comes with long-standing symptoms of generalized fatigue, weakness, questionable fevers, and abnormal LFT's suggesting hepatitis.  The physician noted that he doubts that hepatitis virus is the cause of his symptoms.  He was negative for hepatitis B and C.  His IgG that was positive for hepatitis A was mostly due to prior vaccinations.  Also, hepatitis A is not usually the cause of such extensive persistent symptoms.  Other concerns included to rule out other hepatitis, especially hepatitis E, to rule out other herpes viruses such as CMV and Epstein-Barr virus, especially with a history of lymphocytosis.  The physician was also concerned about other causes of possible hepatitis such as possible autoimmune disease such as autoimmune hepatitis.  It was also mentioned that the LFTs were not significantly elevated, which is atypical for the disease.  Also, infection-wise, there is a possibility of brucellosis, which can affect the liver and cause a variety of syndromes, and TB needs to be considered.  The patient was negative for PPD in the past, and his chest x-ray was negative, but miliary TB can present like this.  The physician noted that the patient had been sick for 10 months so it would be unusual for TB to present like this.  Information was received which pertained to events which occurred after vaccination with hepatitis A virus vaccine inactivated.  This information contained the following adverse experiences: shortness of breath (approximately 09/09/2002); persistent cough, mostly dry (approximately 09/09/2002); stiffness in his joints (approximately 09/09/2003); tremors in his hands (approximately 09/09/2002); and depression (approximately 09/09/2002).  Upon internal review, hepatitis A, severe liver damage, and a positive Epstein-Barr virus IgG were considered to be other important medical events (OMIC).  Additional information has been requested.  All available medical records will be provided upon request." Follow up on 11/05/2003: "Follow up information received on 10/22/2003 indicated that dose of hepatitis A virus vaccine inactivated that the patient received was recalled.  It was noted that the patient contracted hepatitis A due to the hepatitis A virus vaccine inactivated "ineffectiveness which caused him severe pain and suffering.  In addition, the illness prevented him from working as he was unable to fulfill the usual and normal duties of his profession."  The patient also suffered from emotional distress due to the fear of the damage caused by the illness and the lasting effects on his health.  The combined physical, mental and emotional injuries caused by the failure of the vaccine to adequately provide the patient with protection from hepatitis A also resulted in depression which continued to preclude him from working.  Although the exact date is not know, the patient began to suffer from hepatitis A symptoms in approximately December 2001.  On 06/13/2002, the patient "was tested for hepatitis A, and the results showed that the patient was positive for hepatitis A.  The patient has suffered, presently suffers, or will suffer pain and suffering due to the physical effects of hepatitis A, fear of future effects of the virus on his health, mental distress, mental anguish, inconvenience, and/or loss of capacity for the enjoyment of life."  The patient's last day working was 05/09/2002.  He was incapacitated from this date through April 2003.  The patient was hospitalized from 10/23/2003-10/26/2002 and from 12/11/2002-12/14/2002.  The patient has been prescribed two doses of hepatitis B vaccine (manufacturer unknown) which were administered on 06/21/2002 and 08/16/2002, clarithromycin (Biaxin) purchased on 07/16/2002 and 07/26/2002, polyethylene glycol 3350 (+) potassium chloride (+) sodium bicarbonate (+) sodium chloride (+) sodium sulfate (Colyte) purchased on 07/16/2002, pantoprazole sodium (Protonix) purchased on 07/23/2002, hyoscyamine purchased on 07/30/2002, sertraline hydrochloride (Zoloft) purchased on 07/30/2002, paroxetine hydrochloride (Paxil) purchased on 10/14/2002 and 11/21/2002 and 12/14/2002, zolpidem tartrate (Ambien) purchased on 11/21/2002, and mirtazapine (Remeron) purchased on 12/14/2002.  Upon internal review, hepatitis A, severe  liver damage, and a positive Epstein-Barr Virus IgG were considered to be other important medical events (OMIC).  Information was received which pertained to events which occurred after vaccination with hepatitis A virus vaccine inactivated.  This information contained the following adverse experiences: shortness of breath (approximately 09/09/2002); persistent cough, mostly dry (approximately 09/09/2002); stiffness in his joints (approximately 09/09/2002); tremors in his hands (approximately 09/09/2002); and depression (approximately 09/09/2002).  Additional information has been requested.  All available medical records will be provided upon request."