Age: 51.0
Sex: M
Vaccine: IPV, YF
Symptoms: Liver function test abnormal, Malaise, Myalgia, Ocular hyperaemia, Vasculitis
Clinical narrative: Initial info received on 11/6/03 from Yellow Fever meeting work group members regarding an adverse event. It was unknown if the event occurred in the USA; however, for technical purposes box form indicates USA. It is also unknown if pt was hospitalized or required a doctor visit, but required intervention was checked for serious criteria. It was reported by the manufacturer that a 51 year old male pt received a dose of STAMARIL and a dose of IPV on 6/5/03. No additional vaccine info was provided. 20 days later, the pt developed pain in the knees and wrists, malaise, myalgias, arthritis, swollen and red eyes, and vasculitis. On 6/30/03, the pt's ALT was 2215, AST 984, LDH 1016.The pt's liver tests slowly improved. "The conclusion of the VAERS report was biochemical hepatitis and probable yellow fever vaccine associated vascerotropic disease. The pt recovered from these sickness." The pt also received a dose of hep A vaccine 18 days after receiving STAMARIL and IPV. No further info received at this time. From additional info received on 11/19/03 from the CDC and Prevention it was reported that a case was reported by a pharmacist and describes the occurrence of a biochemical hepatitis in a 51 year old male subject receiving hep A (Havrix) injection for prophylaxis. Concurrent medication included a dose of yellow fever vaccine and a dose of inactivated polio vaccine given on 6/5/03. A dose of Havrix was given IM on 6/23/03 prior to a trip. On 6/25/03, the pt developed pain in his knees and wrists and afterwards malaise, generalized myalgias, generalized arthritis, diffuse pain and swollen and red eyes. He also developed spots on his body such as "burst open veins" and reported as vasculitis. On 6/30/03, a blood sample was taken and analysis retrieved increased values for aspartase transaminase, alkaline transaminase, LDH, gamma GT, alkaline phosphates, total bilirubin, and direct bilirubin, C-reactive protein. Negative serologies for hep A, B and C as well as for cytomegalovirus and toxoplasmosis were retrieved. Anti nuclear factor was negative as well. A non-recent Epstein Barr virus infection was also detected. All remaining blood parameters including erythrocyte sed rate, REC, hematocrit, hemoglobin, WBC, leukocyte diff count and coagulation parameters were within normal ranges. The conclusion of these results was biochemical hepatitis. On 7/2/03, repeated lab tests were performed and retrieved the following results: total bilirubin 2.44mg/dl, appartate transaminase 363 U/l, alanine transaminase 1333 U/l, gamma GT 126 U/l, alkaline phosphatase 333 U/l and LDH 505 U/l. Here again all other parameters were within normal ranges except for slightly raised monocytes 16. On 7/7/03, he consulted another physician due to severe red eyes. At that time he still had pain in his knees and wrists as well as symmetrical pain in his arms and legs, as well as myalgia in both biceps. He also reported having painful swollen finger and toe cuticles. Clinical examination was normal except for important red discoloration of both sclerae. Lab tests were again performed which showed slowly improving liver parameters with total bilirubin 1.86mg/dl, direct bilirubin .59mg/dl, aspartate transaminase 59 U/l, alanine trasaminase 482 U/l, gamma GT 89 U/l, alkaline phosphate 121 U/l and LDH 188 U/l. On 7/14/03 blood tests still showed a slow improvements with only raised values for total bilirubin 1.68 mg/dl and alanine trasaminase 110 U/l. All other parameters including WBC, RBC, diff count, prothrombin time, iron and iron binding capacity, urea, creatinine and uric acid were within normal ranges. The overall conclusion was that the complaints of joint pain and myalgia with clear acleritis and biochemical hepatitis would probably fit with a yellow fever vaccine associated with a visertropic disease, such as it is described in patients vaccinated with a 17D derivated yellow fever vaccine. As of 10/9/03, at the time of the last follow-up report, it was reported that the subject had evolved spontaneously as well. He was allowed to travel. He was prescribed malaria prophylaxis in the scope of the recent liver damage. The reporter did not assess a causal relationship. No additional info is expected and this case has been closed.