Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatic failure
Clinical narrative: pancreatic insufficiency/bad reactions after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATIC FAILURE (pancreatic insufficiency/bad reactions after vaccination) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A, 044A21A, 939909 and 061F22) for COVID-19 prophylaxis.     The patient's past medical history included Blood pressure fluctuation, Accident automobile and Thyroidectomy partial (15 years ago). Concurrent medical conditions included Bronchiectasis (Since 10 years ago), Blood pressure high and Wheelchair user (In Wheelchair since 1982 due to car accident) since 1982. Concomitant products included AMLODIPINE for Blood pressure high, LEVOTHYROXINE for Thyroidectomy partial.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2022, received fourth 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/bad reactions after vaccination) (seriousness criterion medically significant). The patient was treated with PANCREATIN (CREON) in 2021 for Pancreatic insufficiency, at an unspecified dose and frequency. At the time of the report, PANCREATIC FAILURE (pancreatic insufficiency/bad reactions after vaccination) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had BP fluctuated before vaccination.  Patient stated that after the 2nd shot in APR2021, he started getting constipated. It got so bad that he had to go to the hospital, and they gave him laxatives. He continued having stomach issues. His body could not digest food. Later he noticed that he was losing muscle in his stomach and lower body, about 4-5 months after vaccination he was diagnosed with Pancreatic insufficiency.  Since the second vaccine he lost a lot of weight. He went from 115-120Lbs to being 95 Lbs. Company comment: This spontaneous case concerns a 64-year-old male patient, with no relevant medical history reported, who experienced the unexpected and serious (medically significant) event of PANCREATIC FAILURE (reported as pancreatic insufficiency), after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine. Since the exact event´s onset date was not reported, latency could not be properly assessed. He firstly experienced constipation and received laxatives. He continued with stomach issues, could not digest food. He lost weight from 115-120Lbs, and about 4-5 months after vaccination he was diagnosed with pancreatic insufficiency. He was treated with pancreatin. No information disclosed about diagnostic tests performed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2024: Live significant follow-up received: Event and references updated.