Sex: M
Vaccine: YF, ANTH, TYP, YF
Symptoms: Fibrin D dimer increased, Hepatic enzyme increased, Hepatic function abnormal, Hypothyroidism, Laboratory test abnormal
Clinical narrative: suspected Yellow fever vaccine-associated viscerotropic disease; multi system organ dysfunction; renal dysfunction; left-sided pleural effusion; coagulopathy; hepatic dysfunction; chest pain; dyspnea; transient hypothyroidism; Raynaud's syndrome; Initial information received on 27-Oct-2020 regarding an unsolicited valid serious case from the health care professional, issued from a literature article.  This case involves a 29 years-old male patient who experienced suspected Yellow fever vaccine-associated viscerotropic disease (YEL-AVD) with multi system organ dysfunction including renal dysfunction, liver dysfunction, left-sided pleural effusion, coagulopathy, chest pain and dyspnea, he was also diagnosed with transient hypothyroidism and Raynaud's syndrome , while he received YELLOW FEVER VACCINE.   The patient's medical history, medical treatments, vaccinations and family history were not provided. The patient received concomitant TYPHOID and ANTHRAX vaccines on the same day of vaccination with yellow fever vaccine  (lot number, dosing details and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.   On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer (lot number, dosing details and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious chest pain and dyspnea two weeks following the administration of YELLOW FEVER VACCINE. These events were assessed as medically significant.  On an unknown date, the patient developed serious suspected YEL-AVD, multi system organ dysfunction including renal dysfunction, liver dysfunction, left-sided pleural effusion, coagulopathy, and transient hypothyroidism (Unknown latency) following the administration of YELLOW FEVER. These events were assessed as medically significant. On an unknown date, the patient developed non-serious Raynaud's syndrome (Raynaud's phenomenon) (Unknown latency) following the administration of YELLOW FEVER VACCINE.  Relevant laboratory test results included: On an unknown date: Blood creatinine and Fibrin D dimer: [elevated], Elevated liver-associated enzymes, Computerized tomogram thorax (Computed tomography pulmonary angiogram): [ruled out pulmonary embolism] and plaque reduction neutralization testing by the agency was not inconsistent with YEL-AVD.  Discussion: "Despite an exhaustive evaluation by rheumatology, pulmonary, endocrinology and immunology an alternative etiology for the patient's signs and symptoms could not be determined. This patient met the viscerotropic disease major criteria of coagulopathy with the elevated fibrin degradation products and narrowly missed the renal major criteria by 0.1 mg/dL and the hepatic major criteria by 2U/L. In the absence of other diagnoses after an exhaustive evaluation, we propose that the patient did in fact have multi-system organ dysfunction consistent with YEL-AVD and suggest a re- evaluation of the current case definition for this rare adverse event following immunization."  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  Information on the batch number was requested.; Sender's Comments: Sanofi company comment for information received on 27-October-2020: This case concerns a 29 years-old male patient who experienced suspected Yellow fever vaccine-associated viscerotropic disease (YEL-AVD) with renal dysfunction, liver dysfunction, left-sided pleural effusion, coagulopathy, chest pain and dyspnea, he was also diagnosed with transient hypothyroidism and Raynaud's syndrome, while he received yellow-fever vaccine produced by unknown manufacturer. The patient received concomitant Typhoid and Anthrax vaccines.  Chest pain and dyspnea started 2 weeks after vaccination with yellow-fever vaccine. The time to onset seems to be compatible with the role of the vaccine. Although the role of the vaccine cannot be excluded in this case, additional information on patient's and family medical history, previous vaccination and tolerance, concomitant medication, vaccine brand name and laboratory investigations confirming the diagnosis of YEL-AVD and ruling out alternate etiologies is needed to fully assess this case.