Sex: U
Vaccine: RAB
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bile duct stenosis, Bile duct stent insertion, Bile duct stent removal
Clinical narrative: biliary strictures; rash, fatigue, and jaundice, periportal lymphadenopathy (Subsequent liver biopsy consistent with cholestatic hepatitis); Literature citation:  Case reference number US-BN-2024-002935 is a spontaneous literature case report, title as stated above, identified on 31-Dec-2024, and concerns a 30-years-old male patient.  The aim of the article was to investigate importance of a thorough history and physical, as well as prompt imaging to establish a diagnosis of biliary strictures.  Biliary strictures can be a challenging diagnosis. Work-up includes basic lab work, abdominal imaging, and even invasive procedures such as endoscopic retrograde cholangiopancreatography (FRCP). Although up to 30% of strictures are benign, the majority are malignant in the form of pancreatic adenocarcinoma and cholangiocarcinoma. As a result, a multidisciplinary approach is vital to differentiate between the 2.  The patient's had no medical history.   The patient's concomitant medication was not provided. As reported, the patient denied alcohol use, drug use, recent travel, new medications/supplements, or high-risk sexual behavior.  On unspecified date, the patient was exposed to a bat and tested positive for rabies.  On unspecified date, unknown time after exposed to bat, reported as 'five days prior arrival', the patient started and completed three series of rabies vaccine along with device constituents prefilled syringe, needle for injection and needle for reconstitution (brand name: unknown; batch number: unknown), at an unknown dose, route, and site of administration, for indication rabies vaccination.   On unspecified date, unknown time after vaccination with rabies vaccine, the patient presented with a rash, fatigue, and jaundice for one week.   On unspecified date, as reported on arrival, the patient's laboratory examinations showed aspartate aminotransferase was165, alanine transaminase was 372, total bilirubin was 9.2, and direct bilirubin was 6.6 (units not reported). Serological and infectious work-up unrevealing. Magnetic resonance cholangiopancreatography showed focal narrowing of common hepatic duct. Endoscopic retrograde cholangiopancreatography (ERCP)/endoscopic ultrasound showed reactive periportal lymphadenopathy causing compression of common hepatic duct. The stricture was dilated and the patient received two biliary stents in left and right hepatic duct. Subsequent liver biopsy consistent with cholestatic hepatitis. Surgical pathology following stent removal negative for malignancy. Liver function tests normalized on outpatient follow-up.  As reported, in individuals with accompanying obstructive jaundice, the stricture should be considered malignant unless proven otherwise. Common etiologies of benign biliary strictures include iatrogenic (post-procedure), chronic pancreatitis, and primary sclerosing cholangitis. Rarely in the literature is reactive lymphadenopathy a cause of obstruction. This case highlights the importance of a thorough history and physical, as well as prompt imaging to establish a diagnosis  At the time of initial report, it was unknown if the patient recovered from the events of 'bile duct stenosis', and 'cholestatic hepatitis'.  The reported assessed the event of 'bile duct stenosis', and 'cholestatic hepatitis' as serious due to criteria of hospitalization, additionally, the events were considered as serious due to criteria of medical significance. The reporter did not provide causality assessment for the events of 'bile duct stenosis', and 'cholestatic hepatitis' as reported the exact incidence of biliary strictures was unknown.  No further information was provided.; Reporter's Comments: A 30-year-old male patient started and completed three series of rabies vaccine for indication rabies vaccination. On unspecified date, an unknown time after the vaccination with rabies vaccine, the patient experienced serious events of bile duct stenosis and cholestatic hepatitis (hospitalization and medical significance). Bile duct stenosis and hepatitis cholestatic are unlisted and unexpected for Rabies Vaccine per CCDS v4 and USPI. The patient's had no medical history, concomitant medication was not provided. As reported, the patient denied alcohol use, drug use, recent travel, new medications or high-risk sexual behaviour. The outcome was unknown. The evaluation did not find enough evidence to suggest a reasonable possibility of a causal relationship nor a plausible biological mechanism of action between the reported events and Rabies Vaccine, therefore the causality is assessed as not related. This case is considered as serious due to hospitalization and medical significance.; Sender's Comments: A 30-year-old male patient started and completed three series of rabies vaccine for indication rabies vaccination. On unspecified date, an unknown time after the vaccination with rabies vaccine, the patient experienced serious events of bile duct stenosis and cholestatic hepatitis (hospitalization and medical significance). Bile duct stenosis and hepatitis cholestatic are unlisted and unexpected for Rabies Vaccine per CCDS v4 and USPI. The patient's had no medical history, concomitant medication was not provided. As reported, the patient denied alcohol use, drug use, recent travel, new medications or high-risk sexual behaviour. The outcome was unknown. The evaluation did not find enough evidence to suggest a reasonable possibility of a causal relationship nor a plausible biological mechanism of action between the reported events and Rabies Vaccine, therefore the causality is assessed as not related. This case is considered as serious due to hospitalization and medical significance.