Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Amylase, Blood test, Dyspepsia, Lipase, Magnetic resonance imaging
Clinical narrative: Pancreatitis; Digestive issues; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (Pancreatitis), DYSPEPSIA (Digestive issues) and PAIN (Pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criteria hospitalization and medically significant), DYSPEPSIA (Digestive issues) (seriousness criterion hospitalization) and PAIN (Pain) (seriousness criterion hospitalization). At the time of the report, PANCREATITIS (Pancreatitis), DYSPEPSIA (Digestive issues) and PAIN (Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Amylase: high (High) High Amylase levels. On an unknown date, Blood test: results not provided She regularly got her blood work done because she had Hashimoto's.. On an unknown date, Lipase: high (High) High lipase levels. On an unknown date, Magnetic resonance imaging: idiopathic diagnosed as idiopathic. On an unknown date, Scan: idiopathic Diagnosed as idiopathic.         The patient ended up in the hospital with pancreatitis with high amylase lipase levels. She mentioned that they were off the charts. She regularly got her blood work done because she had hashimoto's. This happened 3-4 weeks after the second dose. She also had digestive issues, pain, this all caused hospitalization. She had MRI, multiple imaging scans to see if it was gallbladder or something else, it was diagnosed as idiopathic.  No treatment information was provided. Company comment: This is a spontaneous case concerning a 61-year-old female patient with no relevant medical history, who experienced the unexpected, adverse event of especial interest of pancreatitis and serious event of dyspepsia and pain. The events occurred 3-4 weeks after the second dose of mRNA-1273 vaccine. Patient´s had high blood amylase and lipase levels. Magnetic resonance imaging and scan imaging diagnosed as idiopathic pancreatitis. The events dyspepsia and pain were reported secondary to hospitalization. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-407218 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 61-year-old female patient with no relevant medical history, who experienced the unexpected, adverse event of especial interest of pancreatitis and serious event of dyspepsia and pain. The events occurred 3-4 weeks after the second dose of mRNA-1273 vaccine. Patient´s had high blood amylase and lipase levels. Magnetic resonance imaging and scan imaging diagnosed as idiopathic pancreatitis. The events dyspepsia and pain were reported secondary to hospitalization. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.