Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Frequent bowel movements, Gastrointestinal carcinoma
Clinical narrative: GASTRO CANCER; LOSS OF APPETITE; INCREASE IN BOWEL MOVEMENTS; Loss of taste; This spontaneous case was reported by a patient and describes the occurrence of GASTROINTESTINAL CARCINOMA (GASTRO CANCER) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PANCREATIN (CREON) for an unknown indication.    No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started PANCREATIN (CREON) (Oral) at an unspecified dose. On an unknown date, the patient experienced GASTROINTESTINAL CARCINOMA (GASTRO CANCER) (seriousness criterion medically significant), DECREASED APPETITE (LOSS OF APPETITE), FREQUENT BOWEL MOVEMENTS (INCREASE IN BOWEL MOVEMENTS) and AGEUSIA (Loss of taste). At the time of the report, GASTROINTESTINAL CARCINOMA (GASTRO CANCER), DECREASED APPETITE (LOSS OF APPETITE), FREQUENT BOWEL MOVEMENTS (INCREASE IN BOWEL MOVEMENTS) and AGEUSIA (Loss of taste) outcome was unknown.            Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events of GASTRO CANCER, LOSS OF APPETITE, INCREASE IN BOWEL MOVEMENTS and LOSS OF TASTE with respect to creon was not provided.   Opinion is that there is no reasonable possibility that the event of GASTRO CANCER is related to CREON(PANCREATIN). Opinion is that the events of LOSS OF APPETITE, INCREASE IN BOWEL MOVEMENTS and LOSS OF TASTE are not assessable.  Treatment details were not given.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company comment: This spontaneous case concerns an elderly male patient of an unspecified age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Gastrointestinal carcinoma and unexpected non-serious AESI Ageusia after receiving a dose of mRNA-1273 vaccine and co-suspect drug Pancreatin (start date and indication for use were not reported). The onset date of the event was not reported. The events were reported along with the non-serious events of decreased appetite and frequent bowel movements. Clinical course and treatment details were not reported. The outcome of events was reported as unknown. Co-suspect Pancreatin could be considered as a confounder. Patient received 2 doses of mRNA-1273 vaccine at an interval of 27 days. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed serious based on medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an elderly male patient of an unspecified age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Gastrointestinal carcinoma and unexpected non-serious AESI Ageusia after receiving a dose of mRNA-1273 vaccine and co-suspect drug Pancreatin (start date and indication for use were not reported). The onset date of the event was not reported. The events were reported along with the non-serious events of decreased appetite and frequent bowel movements. Clinical course and treatment details were not reported. The outcome of events was reported as unknown. Co-suspect Pancreatin could be considered as a confounder. Patient received 2 doses of mRNA-1273 vaccine at an interval of 27 days. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed serious based on medical judgement.