Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin abnormal, C-reactive protein, Cholecystitis acute, Computerised tomogram, Endoscopic retrograde cholangiopancreatography
Clinical narrative: Acute transformation of cholecystitis to choledocholithiasis; Cholecystitis acute; Asymptomatic COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of BILE DUCT STONE (Acute transformation of cholecystitis to choledocholithiasis) and CHOLECYSTITIS ACUTE (Cholecystitis acute) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: (PRIVACY)    The patient's past medical history included Cholecystectomy. Concurrent medical conditions included Hypertension, Hyperlipidemia and Type 2 diabetes mellitus. Concomitant products included CEFTRIAXONE and METRONIDAZOLE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BILE DUCT STONE (Acute transformation of cholecystitis to choledocholithiasis) (seriousness criteria hospitalization and medically significant), CHOLECYSTITIS ACUTE (Cholecystitis acute) (seriousness criterion medically significant) and ASYMPTOMATIC COVID-19 (Asymptomatic COVID-19). The patient was treated with Surgery for Bile duct stone. At the time of the report, BILE DUCT STONE (Acute transformation of cholecystitis to choledocholithiasis) had resolved and CHOLECYSTITIS ACUTE (Cholecystitis acute) and ASYMPTOMATIC COVID-19 (Asymptomatic COVID-19) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: 58 u/l 58 U/L on day 1 (On admission), 583 u/l 583 U/L on day 2 and 260 u/l 260 U/L - Post- ERCP. On an unknown date, Aspartate aminotransferase: 62 u/l 62 U/L on day 1 (On admission), 944 u/l 944 U/L on day 2 and 69 u/l 69 U/L - Post- ERCP. On an unknown date, Bilirubin conjugated abnormal: 0.2 mg/dl 0.2 mg/dL on day 1 (On admission), 2.7 mg/dl 2.7 mg/dL on day 2 and 0.9 mg/dl 0.9 mg/dL - Post- ERCP. On an unknown date, Blood bilirubin abnormal: 0.6 mg/dl 0.6 mg/dL on day 1 (On admission), 2.9 mg/dl 2.9 mg/dL on day 2 and 1.4 mg/dl 1.4 mg/dL - Post- ERCP. On an unknown date, C-reactive protein: 182.3 mg/l 182.3 mg/L. On an unknown date, Computerised tomogram: normal (normal) revealed no appreciable abnormality.. On an unknown date, Endoscopic retrograde cholangiopancreatography: normal (normal) patient experienced a rapid normalization of liver enzymes and improvement of his abdominal symptoms. and normal (normal) after surgery ERCP revealed dilated CBD with evidence of biliary sludge, but without evidence of stones. On an unknown date, Helicobacter test: negative (Negative) Negative. On an unknown date, Hepatic enzyme: elevated Patient developed an acute elevation of liver enzymes suggesting choledocholithiasis and normal After cholecystectomy the patient experienced a rapid normalization of liver enzymes. On an unknown date, Laboratory test: normal (normal) metabolic panel, complete blood count, lipase, coagulation panels and blood cultures were all unremarkable. Pertinently, the remaining battery of blood tests, including full blood count (FBC), alkaline phosphatase, and cardiopulmonary tests were unremarkable.. On an unknown date, SARS-CoV-2 test: positive (Positive) Patient was incidentally found to be positive for COVID-19 on routine surveillance testing.. On an unknown date, Ultrasound abdomen: the presence of a 2.3 cm stone in the gallbladder the presence of a 2.3 cm stone in the gallbladder neck consistent with acute cholecystitis without dilated common bile duct (CBD).. On an unknown date, Ultrasound biliary tract: abnormal (abnormal) There is a presence of a 2.3 cm stone in the gallbladder neck consistent with acute cholecystitis without dilated common bile duct (CBD).. On an unknown date, Ultrasound scan: abnormal (abnormal) Confirmed acute cholecystitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BILE DUCT STONE (Acute transformation of cholecystitis to choledocholithiasis) and CHOLECYSTITIS ACUTE (Cholecystitis acute) to be possibly related and ASYMPTOMATIC COVID-19 (Asymptomatic COVID-19) to be not applicable.    The patient was presented with 4 days of non-radiating RUQ abdominal pain worsening with fatty meals. His symptom started abruptly with associated nausea and non-bloody vomiting. In the emergency department RUQ ultrasound was performed which was significant for gallbladder sludge and the presence of a 2.3 cm stone in the gallbladder neck consistent with acute cholecystitis without dilated common bile duct (CBD). General surgery was consulted with a plan for non-emergent cholecystectomy. The patient was subsequently started on broad spectrum antibiotics coverage with ceftriaxone 1 g every 24 h and metronidazole five hundred milligrams every 8 h along with intravenous (IV) fluid administration. He was incidentally found to be COVID-19 positive on routine surveillance testing, but did not have any respiratory distress such as shortness of breath, pleuritic chest pain or changes in his exercise tolerance  Patient was incidentally found to be COVID-19 positive on routine surveillance testing, but did not have any respiratory distress such as shortness of breath, pleuritic chest pain or changes in his exercise tolerance.  Furthermore, he did not require any supplemental oxygen and previously received two doses of the Moderna vaccine. As the patient was asymptomatic, COVID-19 treatment (which included dexamethasone, remdesivir, and tocilizumab) was not initiated.  Patient was followed up as an outpatient post-surgery with improvement of his abdominal symptoms and his lab values normalized.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow up received by safety on 17-NOV-2021 included an email with the team which contains new information. Added Correspondence contact in general tab; medical history, lab tests in patient tab; concomitants in product tab; new events and hospitalization criteria in events tab.; Sender's Comments: This literature-non-study case concerns a 47-year-old male patient with relevant medical history who experienced serious unexpected events of acute cholecystitis and bile duct stone, as well as non-serious unexpected adverse event of special interest Asymptomatic COVID-19. The events occurred unspecified time the second dose of the mRNA-1273 (Moderna COVID-19 vaccine) . Reportedly, the patient presented with 4 days of non-radiating RUQ abdominal pain worsening with fatty meals. His symptom started abruptly with associated nausea and non-bloody vomiting. Ultrasound result was consistent with acute cholecystitis without dilated common bile duct (CBD). General surgery was consulted with a plan for non-emergent cholecystectomy. The patient was subsequently started on broad-spectrum antibiotics coverage along with intravenous (IV) fluid administration. He was incidentally found to be COVID-19 positive on routine surveillance testing, but was asymptomatic. On the day of surgery,the diagnosis of choledocholithiasis without cholangitis was made and ERCP was performed to relieve biliary obstruction. The authors considered the events as unlikely related to mRNA-1273 and possibly related to COVID-19. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.