Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colitis, Colonoscopy, Pancreatic failure, Pancreatitis acute
Clinical narrative: Severe pancreatic insufficiency; Colitis/ colon inflammation; Developed acute pancreatitis 3 weeks after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATIC FAILURE (Severe pancreatic insufficiency), PANCREATITIS ACUTE (Developed acute pancreatitis 3 weeks after the 2nd dose) and COLITIS (Colitis/ colon inflammation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 024M20A) for COVID-19 vaccination.     The caller had no history of a  positive Covid test until 26Apr2022.  Concomitant products included PREDNISONE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PANCREATITIS ACUTE (Developed acute pancreatitis 3 weeks after the 2nd dose) (seriousness criterion medically significant). On an unknown date, the patient experienced PANCREATIC FAILURE (Severe pancreatic insufficiency) (seriousness criterion medically significant) and COLITIS (Colitis/ colon inflammation) (seriousness criterion medically significant). The patient was treated with PANCRELIPASE for Pancreatic insufficiency, at an unspecified dose and frequency and MESALAMINE for Colitis, at an unspecified dose and frequency. At the time of the report, PANCREATIC FAILURE (Severe pancreatic insufficiency) had not resolved and PANCREATITIS ACUTE (Developed acute pancreatitis 3 weeks after the 2nd dose) and COLITIS (Colitis/ colon inflammation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Colonoscopy: colitis colitis.         Patient reported her experiences after receiving 2 doses (2nd dose lot # 002B21A on 130Mar02021) and a full 3rd dose (lot # 032F21A on 03 Nov02021) in anticipation of going on Prednisone which she never ended up taking of the Moderna Covid-19 Vaccine.  On 04-Apr-2021 patient  started experiencing symptoms of what patient  thought was food poisoning including nausea, upset stomach, severe diarrhea.   This case was linked to MOD-2022-554794.  Company comment: This is a spontaneous case concerning a 65-year-old, female patient with no reported medical history and with vaccine history of receiving mRNA-1273 vaccine as first dose of Covid-19 vaccine, who experienced the unexpected serious (medically significant) AESI event of acute pancreatitis and the unexpected serious (medically significant) event of colitis. The event acute pancreatitis occurred 3 weeks after the second dose of mRNA-1273 vaccine administration while the event colitis exact occurrence unknown with respect to the second dose of mRNA-1273 vaccine administration. Allegedly the events were described as, 22 days after the second dose of mRNA-1273 vaccine the patient began having nausea, upset stomach and severe diarrhea then a week later patient began having back pain starting in one shoulder that migrated to other shoulder and involved her upper back and neck to the point where patient couldn't turn her head and couldn't get out of bed. The diarrhea continued for 4 weeks, and the patient lost 20 pounds. On unknown date, the patient has severe pancreatic insufficiency for which the patient takes Pancrelipase. Approximately 3-4 months after the second dose of mRNA-1273 vaccine the patient underwent colonoscopy with unspecified result but reported that the patient began taking Mesalamine for Colitis. Approximately 5-6 months after the second dose of mRNA-1273 vaccine patient began having erythema nodosum in which according to her doctor is related to colon inflammation. Approximately 7-8 months after the second dose of mRNA-1273 vaccine the patient underwent a sigmoidoscopy which showed quiescent colitis with structural damage to her colon but no active inflammation. The outcome of the events was unknown. The patient's age remain confounder for the event colitis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 65-year-old, female patient with no reported medical history and with vaccine history of receiving mRNA-1273 vaccine as first dose of Covid-19 vaccine, who experienced the unexpected serious (medically significant) AESI event of acute pancreatitis and the unexpected serious (medically significant) event of colitis. The event acute pancreatitis occurred 3 weeks after the second dose of mRNA-1273 vaccine administration while the event colitis exact occurrence unknown with respect to the second dose of mRNA-1273 vaccine administration. Allegedly the events were described as, 22 days after the second dose of mRNA-1273 vaccine the patient began having nausea, upset stomach and severe diarrhea then a week later patient began having back pain starting in one shoulder that migrated to other shoulder and involved her upper back and neck to the point where patient couldn't turn her head and couldn't get out of bed. The diarrhea continued for 4 weeks, and the patient lost 20 pounds. On unknown date, the patient has severe pancreatic insufficiency for which the patient takes Pancrelipase. Approximately 3-4 months after the second dose of mRNA-1273 vaccine the patient underwent colonoscopy with unspecified result but reported that the patient began taking Mesalamine for Colitis. Approximately 5-6 months after the second dose of mRNA-1273 vaccine patient began having erythema nodosum in which according to her doctor is related to colon inflammation. Approximately 7-8 months after the second dose of mRNA-1273 vaccine the patient underwent a sigmoidoscopy which showed quiescent colitis with structural damage to her colon but no active inflammation. The outcome of the events was unknown. The patient's age remain confounder for the event colitis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.