Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Influenza like illness, Myocardial infarction, Pain, Skin fissures
Clinical narrative: Heart attack; Flu like symptoms; Ache; Skin fissures; Skin bleeding; Blood in stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool) and MYOCARDIAL INFARCTION (Heart attack) in a 68-year-old 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 ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    The patient's past medical history included Alcohol use from 1974 to 1984, Tobacco user from 1974 to 1984 and Heart attack in 2018. Concurrent medical conditions included Ulcerative colitis. Concomitant products included VERAPAMIL, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), AZATHIOPRINE, VALPROATE SEMISODIUM (DIVALPROEX), QUETIAPINE FUMARATE (SEROQUEL), TEMAZEPAM, LORATADINE and BELANTAMAB MAFODOTIN for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In April 2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced SKIN FISSURES (Skin fissures), SKIN HAEMORRHAGE (Skin bleeding), HAEMATOCHEZIA (Blood in stool) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Ache). In April 2021, MYOCARDIAL INFARCTION (Heart attack) had resolved. At the time of the report, SKIN FISSURES (Skin fissures) and SKIN HAEMORRHAGE (Skin bleeding) had not resolved, HAEMATOCHEZIA (Blood in stool) was resolving and INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medications were reported.  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 is a spontaneous case concerning a 68-year-old male patient with medical history of heart attack and ulcerative colitis, who experienced the unexpected, serious (hospitalization and medically significant) adverse event of Myocardial infarction and the unexpected, serious (medically significant) event of Haematochezia, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccinations, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event Myocardial infarction resolved within the same month from the onset and the event Haematochezia was resolving at the time of the report. History of heart attack remains a risk factor for the event of Myocardial infarction. Medical history of ulcerative colitis remains a risk factor for the event of Haematochezia. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 68-year-old male patient with medical history of heart attack and ulcerative colitis, who experienced the unexpected, serious (hospitalization and medically significant) adverse event of Myocardial infarction and the unexpected, serious (medically significant) event of Haematochezia, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccinations, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event Myocardial infarction resolved within the same month from the onset and the event Haematochezia was resolving at the time of the report. History of heart attack remains a risk factor for the event of Myocardial infarction. Medical history of ulcerative colitis remains a risk factor for the event of Haematochezia. The benefit-risk relationship of mRNA-1273 is not affected by this report.