Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Blood bilirubin, Chromaturia, Computerised tomogram, Flatulence
Clinical narrative: jaundice; pruritus; something must be eating away his muscle tissue; ducts in his liver were sclerosed; urinating brown colored urine (coke colored)/urine was like someone put a red dye on it; had some gas; abdominal area was distended; fever (103F); left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC FIBROSIS (ducts in his liver were sclerosed), JAUNDICE (jaundice), PRURITUS (pruritus) and RHABDOMYOLYSIS (something must be eating away his muscle tissue) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis, Diabetes mellitus (Type II) and Fatty liver. Concomitant products included OCRELIZUMAB (OCREVUS) for Multiple sclerosis.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm soreness). On 04-Mar-2021, the patient experienced PYREXIA (fever (103F)). On 05-Mar-2021, the patient experienced ABDOMINAL DISTENSION (abdominal area was distended) and FLATULENCE (had some gas). In March 2021, the patient experienced HEPATIC FIBROSIS (ducts in his liver were sclerosed) (seriousness criteria hospitalization and medically significant). On 26-Mar-2021, the patient experienced JAUNDICE (jaundice) (seriousness criterion hospitalization) and PRURITUS (pruritus) (seriousness criterion hospitalization). On 05-Aug-2021, the patient experienced CHROMATURIA (urinating brown colored urine (coke colored)/urine was like someone put a red dye on it). On an unknown date, the patient experienced RHABDOMYOLYSIS (something must be eating away his muscle tissue) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 08-Mar-2021 to 18-Mar-2021 due to HEPATIC FIBROSIS and RHABDOMYOLYSIS, then from 26-Mar-2021 to 01-Apr-2021 due to JAUNDICE and PRURITUS. The patient was treated with LACTULOSE ongoing since an unknown date at a dose of 30 milliliter three times a day; CHOLESTYRAMINE for Pruritus, at an unspecified dose and frequency; ACETAMINOPHEN for Fever, at an unspecified dose and frequency and GASEX for Urination abnormal NOS, at an unspecified dose and frequency. On 07-Mar-2021, VACCINATION SITE PAIN (left arm soreness) had resolved. At the time of the report, HEPATIC FIBROSIS (ducts in his liver were sclerosed), JAUNDICE (jaundice), PRURITUS (pruritus), RHABDOMYOLYSIS (something must be eating away his muscle tissue), ABDOMINAL DISTENSION (abdominal area was distended), CHROMATURIA (urinating brown colored urine (coke colored)/urine was like someone put a red dye on it), FLATULENCE (had some gas) and PYREXIA (fever (103F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Blood bilirubin: high (High) high. On 07-Mar-2021, Computerised tomogram: abnormal (abnormal) They saw that the ducts in his liver were sclerosed. On 07-Mar-2021, Hepatic enzyme: high (High) high. On 07-Mar-2021, Magnetic resonance imaging: abnormal (abnormal) They saw that the ducts in his liver were sclerosed.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient advised not to get second dose of vaccine. He was admitted from 08Mar-18Mar2021 - where a CT Scan, MRI and liver biopsy were done. Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected.