Sex: M
Vaccine: RAB, RAB
Symptoms: Faeces pale, Headache, Hepatitis cholestatic, Hepatosplenomegaly, Hyperbilirubinaemia
Clinical narrative: Serum Sickness-Like Reaction After Postexposure Rabies Prophylaxis; intermittent fevers; diffuse rash; biliary stenosis likely secondary to reactive periportal lymphadenopathy; obstructive jaundice; headaches; myalgias; chills; scleral icterus; cholestatic hepatitis; Dark discoloration of the urine; pale stools; moderate transaminitis; scattered macular rash involving the chest, abdomen, back, and extremities; two episodes of black, tarry stools; biliary stenosis following serum sickness-like reaction; mild hepatosplenomegaly; hepatomegaly; possible small gallstones; mild splenomegaly; acute blood loss anemia; Initial information received on 23-Oct-2023 by health care professional regarding an unsolicited valid serious case issued from a literature article:   This case involves a 30-year-old male patient who experienced serum sickness-like reaction after postexposure rabies prophylaxis (serum sickness-like reaction), obstructive jaundice (jaundice cholestatic) and cholestatic hepatitis (hepatitis cholestatic), biliary stenosis (bile duct stenosis) all following serum sickness-like reaction while receiving vaccines RABIES IMMUNE GLOBULIN, HUMAN and RABIES (HDC) VACCINE [IMOVAX RABIES].  On an unknown date, the patient received a dose of suspect rabies immune globulin, human and not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect rabies (HDC) vaccine lot number not reported via unknown route in unknown administration site.  On an unknown date, (unknown latency) the previously healthy patient presented to the Emergency Department (ED) with complaints of fever (pyrexia), rash, and jaundice after receiving three of the postexposure human diploid rabies vaccines (HDCV) and human rabies immunoglobulin (HRIG). He had no prior medical history and no known drug allergies. He had a rabies-positive bat in his home 20 days prior to hospital presentation and had received postexposure vaccinations on days 4, 7, and 11 after the bat exposure. He additionally received HRIG with first postexposure vaccination. This patient did not have any bites or wounds from the bat exposure. After the patient's first vaccination he started having intermittent fevers, headaches (headache), myalgias (myalgia), and chills. Dark discoloration of the urine (chromaturia) began after the second vaccination. He presented to the ED 4 days after his third vaccination, at which point he had developed pale stools (faeces pale), diffuse rash (rash), and jaundice. On physical examination, the patient had scleral icterus (ocular icterus), diffuse jaundice of the skin, and a scattered macular rash involving the chest, abdomen, back, and extremities (rash macular). He did not show any signs of distress, airway compromise, or abdominal tenderness. A computed tomography (CT) scan of the abdomen and pelvis was significant for mild hepatosplenomegaly (hepatosplenomegaly). Initial laboratory values showed a cholestatic pattern with a moderate transaminitis (hypertransaminasaemia) (aspartate aminotransferase 165 U/L [< 41 U/L], alanine aminotransferase 372 U/L [< 56 U/L]) and a mixed hyperbilirubinemia with a total bilirubin of 9.2 mg/dL (0.2-1.0 mg/dL) and direct bilirubin level of 6.6 mg/dL (0.0-0.2 mg/dL). There were no prior laboratory values available. The presumptive diagnosis of serum sickness was made. The treatment of serum sickness is supportive, as it is most commonly a self-limiting illness. The patient was admitted to the hospital for 8 days, during which hematology/oncology, gastroenterology, and infectious disease services were consulted. Multiple imaging studies to exclude primary hepatic disease were completed, including CT of the abdomen, hepatic Doppler ultrasound, magnetic resonance imaging of the liver, and complete ultrasound of the abdomen. These studies were completed at days 4, 5, 8, and 16 after the last HDCV dose, respectively. The CT and hepatic Doppler did not reveal any hepatic findings. The magnetic resonance imaging showed focal narrowing of the superior common hepatic duct for which endoscopic retrograde cholangiopancreatography was recommended, and the complete abdominal ultrasound revealed hepatomegaly. Other incidental findings on these imaging studies included possible small gallstones (Cholelithiasis) and mild splenomegaly (splenomegaly). Endoscopic retrograde cholangiopancreatography noted stricture of the common hepatic duct and bilateral intrahepatic stents were placed, and the patient also underwent a sphincterotomy. The specialists believe the strictures were caused by reactive periportal lymphadenopathy. The patient's C3 level was at the high limit of normal at 180 mg/dL (90-180 mg/dL) and C4 was elevated at 48.9 mg/dL (10-40 mg/dL). The magnetic resonance imaging showed, alanine aminotransferase 3 tributed to post-sphincterotomy blood loss. Liver biopsy was performed during this hospitalization and showed cholestatic hepatitis. The patient's biliary stent was removed almost 3 months after initial placement. On a comprehensive metabolic panel obtained 4 months after initial hospitalization, aspartate aminotransferase and bilirubin had returned to normal and alanine aminotransferase was only slightly elevated at 63 U/L (<56 U/L).  Action taken: not applicable for all events Corrective treatment: bilateral intrahepatic stents were placed, and the patient also underwent a sphincterotomy for biliary stenosis and unknown for rest events Outcome: Recovering for all events Seriousness criteria: hospitalization for Serum sickness-like reaction; medically significant and hospitalization for rest events Reporter causality: Related with all events.; Sender's Comments: Sanofi company comment dated 30-OCT-2023: This case involves a 30-year-old male patient who experienced serum sickness-like reaction after postexposure rabies prophylaxis (serum sickness-like reaction), obstructive jaundice (jaundice cholestatic) and cholestatic hepatitis (hepatitis cholestatic), biliary stenosis (bile duct stenosis) all following serum sickness-like reaction while receiving vaccines RABIES (HDC) VACCINE [IMOVAX RABIES]. Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.