Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatitis, Post-acute COVID-19 syndrome, SARS-CoV-2 test, Urine analysis, Weight
Clinical narrative: inflammation in his pancreas; weight loss; long covid; This spontaneous case was reported by a physician and describes the occurrence of PANCREATITIS (inflammation in his pancreas) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 026120A, 032L20A and 037F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary artery bypass. Concurrent medical conditions included Hypertension and Hypocholesteremia.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2022, the patient experienced POST-ACUTE COVID-19 SYNDROME (long covid). On an unknown date, the patient experienced PANCREATITIS (inflammation in his pancreas) (seriousness criterion medically significant) and WEIGHT DECREASED (weight loss). At the time of the report, PANCREATITIS (inflammation in his pancreas) had resolved and WEIGHT DECREASED (weight loss) and POST-ACUTE COVID-19 SYNDROME (long covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, SARS-CoV-2 test: (Positive) His COVID was chronic, long COVID. On an unknown date, Urine analysis: he was spilling glucose in his urine. On an unknown date, Weight: He lost 30 pounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PANCREATITIS (inflammation in his pancreas) to be not related. No further causality assessments were provided for WEIGHT DECREASED (weight loss) and POST-ACUTE COVID-19 SYNDROME (long covid).    It was reported that He had the first two spaced COVID vaccines and two boosters. Then six months after that, he went to another county and got COVID (he thinks it may have been a different strain). This would have been November of 2022. He was sick. He took two home kits that confirmed he was positive. His COVID was chronic, long COVID. He had cloudy mentation, muscle aches, and low grade fever. He was experiencing weight loss probably related to the fact that his pancreas was being affected and he was spilling glucose in his urine. Apparently he needed a lot of treatment in the beginning and his pancreas has made a recovery. His diabetologist thinks that the long COVID with inflammation in his body caused inflammation in his pancreas. He thinks that he recovered but might not be able to come off of treatment.  Company comment: This is a Spontaneous case concerning a 72-year-old male patient with medical history of coronary artery bypass and concurrent hypertension and hypocholesterolaemia who experienced the unexpected and serious (medically significant) event of pancreatitis which occurred approximately 6 months after the fourth dose of mRNA-1273 for COVID-19 Vaccination. It was reported that the patient experienced signs and symptoms of glucose in his urine and weight loss along with other symptoms which were related to post-acute-COVID-19 syndrome as muscle aches, cloudy mentation and low-grade fever. He was also later diagnosed with diabetes which was able to be controlled with diet and oral hypoglycemic agents after the pancreas recovery. Diagnostic workup results and treatment details for pancreatitis were not provided. It was reported that his diabetologist thinks that the long COVID with inflammation in his body caused inflammation in his pancreas. Medical history of COVID-19 remains as a contributory risk factor. Concurrent hypocholesterolaemia, cardiovascular risk factors and patient's advanced age remain confounding. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-741988 (Linked Report).; Sender's Comments: Company comment: This is a Spontaneous case concerning a 72-year-old male patient with medical history of coronary artery bypass and concurrent hypertension and hypocholesterolaemia who experienced the unexpected and serious (medically significant) event of pancreatitis which occurred approximately 6 months after the fourth dose of mRNA-1273 for COVID-19 Vaccination. It was reported that the patient experienced signs and symptoms of glucose in his urine and weight loss along with other symptoms which were related to post-acute-COVID-19 syndrome as muscle aches, cloudy mentation and low-grade fever. He was also later diagnosed with diabetes which was able to be controlled with diet and oral hypoglycemic agents after the pancreas recovery. Diagnostic workup results and treatment details for pancreatitis were not provided. It was reported that his diabetologist thinks that the long COVID with inflammation in his body caused inflammation in his pancreas. Medical history of COVID-19 remains as a contributory risk factor. Concurrent hypocholesterolaemia, cardiovascular risk factors and patient's advanced age remain confounding. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-741988:Same patient, Bivalent moderna vaccine