Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pancreatitis acute, Ultrasound pancreas, Urinary system X-ray, X-ray
Clinical narrative: acute pancreatitis; kidney inflammation; liver inflammation; gallbladder inflammation; This spontaneous case was reported by a patient and describes the occurrence of PANCREATITIS ACUTE (acute pancreatitis), NEPHRITIS (kidney inflammation), HEPATITIS (liver inflammation) and CHOLECYSTITIS (gallbladder inflammation) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080473) for COVID-19 prophylaxis.     The patient's past medical history included Sickness, Knee replacement (2 artificial knees), Pacemaker insertion (cardiac) and Surgery. Previously administered products included for COVID-19 prophylaxis: Moderna. Past adverse reactions to the above products included No adverse effect with Moderna.    On 20-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In September 2024, the patient experienced PANCREATITIS ACUTE (acute pancreatitis) (seriousness criteria hospitalization and medically significant), NEPHRITIS (kidney inflammation) (seriousness criteria hospitalization and medically significant), HEPATITIS (liver inflammation) (seriousness criteria hospitalization and medically significant) and CHOLECYSTITIS (gallbladder inflammation) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Sep-2024 to 08-Oct-2024 due to CHOLECYSTITIS, HEPATITIS, NEPHRITIS and PANCREATITIS ACUTE. The patient was treated with Oxycodone hydrochloride at an unspecified dose and frequency and Paracetamol (Tylenol) at an unspecified dose and frequency. In 2024, NEPHRITIS (kidney inflammation) and HEPATITIS (liver inflammation) had resolved. At the time of the report, PANCREATITIS ACUTE (acute pancreatitis) and CHOLECYSTITIS (gallbladder inflammation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2024, Abdominal X-ray: inflamed. On 22-Sep-2024, Ultrasound pancreas: acute pancreatitis. On 22-Sep-2024, Urinary system X-ray: inflamed. On 22-Sep-2024, X-ray: inflamed. In October 2024, Endoscopy: acute pancreatitis.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Patient reported that the recent dose he had was probably number six or number seven. On 21st Sep, he had a slight fever which he thought was normal and was fine on Sunday, the 22nd Sep. But, at around 1:30PM, had stomach cramps started and with chills. He started shaking all over. The patient was taken to the hospital. X-rays of abdomen, gallbladder, kidney, liver and pancreas were done, all were inflamed. The doctor then added that the patient had acute pancreatitis. Right away, he was put on two different IV with two different antibiotics and placed him in a room. For two weeks, he had nothing but a liquid diet broth, Jell-o, and juice. Reporter's first week at the hospital, CT scans were done with one with contrast and the other which doesn't have contrast. With the one with contrast, he was told that another one with ultrasound was needed and so he was transferred to another hospital to have it done. When the reporter was on the other hospital, the vaccine can cause acute pancreatitis which was said by the doctor to the reporter after the endoscopy with ultrasound was done. Reporter said that the doctor had to put a stent in his pancreas and went through the gallbladder, kidneys, liver, and everything. The doctor told him he was highly inflamed. He was told that the inflammation was high and said that his condition was not going to go away overnight. After suffering for two weeks with all the antibiotics, the liver and the kidneys were back to normal function without any problems except for the pancreas and the gallbladder. He had to have his gallbladder removed which the reporter stated was his current state. On 08OCT2024, he was discharged from the hospital. Reporter added that he had been in a lot of abdominal discomfort because of his gallbladder. Patient was on Oxycodone and Tylenol to help ease the pain.   This case was linked to US-MODERNATX, INC.-MOD-2024-776196 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-776196:Reporter case