Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pancreatic cyst, Pancreatic enzyme replacement therapy, Pancreatic enzymes abnormal, Pancreatic failure, Stress
Clinical narrative: covid 19; pancreatic insufficiency; This spontaneous case was reported by a patient and describes the occurrence of PANCREATIC FAILURE (pancreatic insufficiency) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 037B21A and 007B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis C (The patient was treated for Hepatitis C.).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PANCREATIC FAILURE (pancreatic insufficiency) (seriousness criterion medically significant). In June 2022, the patient experienced COVID-19 (covid 19). At the time of the report, PANCREATIC FAILURE (pancreatic insufficiency) and COVID-19 (covid 19) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported that that after Moderna Covid-19 vaccine on Mar2021 almost immediately after that, patient had digestive symptoms of diarrhea. In the fall of 2021 patient was diagnosed with pancreatic insufficiency and now patient was on enzymes to digest food. Patient concerned that maybe something in her system was impacted by the vaccine. Patient mentioned that this changed her life entirely, now patient was used to it. Patient needs to perform scans of her pancreas every 2 years. It would have never occurred to her that this was a pancreatic issue, patient did not report it right away, because patient thought that the digestive issues were just because patient was stressed by all the Covid situation. The doctor figured the problem right away. The symptoms started within the month in between the first and the second dose (Mar-Apr-May 2021). Patient continued receiving the vaccines after this, patient also received the most updated Moderna vaccine, but the problem was just with the first and second dose. Patient not had additional lot number and administration dates at this time. Patient had Covid-19 on Jun2022 with very mild symptoms and because of Covid potentially her testosterone levels disappeared. Patient was being treated with hormones.  Company comment:  This spontaneous case concerns 58-year-old female, with medical history of Hepatitis C in treatment, who experienced the unexpected serious, (medically significant) event of pancreatic failure, which occurred after the first dose of mRNA-1273 vaccine. She also received the second and third doses of mRNA-1273 within the appropriate schedule of vaccination. It was reported that almost immediately after the first dose of mRNA-1273, the patient had digestive symptoms of diarrhea. In the fall of that year, the patient was diagnosed with pancreatic insufficiency and was on enzymes to digest food. Patient needed to perform scans of her pancreas every 2 years. Patient thought that the digestive issues were just because patient was stressed by all the COVID-19 situation. The symptoms started within the month in between the first and the second dose. Patient continued receiving the vaccines after this, patient also received the most updated Moderna vaccine, but the problem was just with the first and second dose. Patient had COVID-19 with very mild symptoms approximately 7 months after the third dose. She said that because of COVID-19 potentially her testosterone levels disappeared. Patient was being treated with hormones. The medical history of Hepatitis C could be a contributory factor for pancreatic failure. The benefit-risk relationship of mRNA-1273 is not affected by this report.