Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Interchange of vaccine products, Myocardial infarction, Thrombosis
Clinical narrative: Hemorrhaging; Multiple heart attacks; Heavy clotting; patient received JANSSEN COVID-19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Hemorrhaging), MYOCARDIAL INFARCTION (Multiple heart attacks) and THROMBOSIS (Heavy clotting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Hemorrhaging) (seriousness criteria death and medically significant), MYOCARDIAL INFARCTION (Multiple heart attacks) (seriousness criteria death and medically significant), THROMBOSIS (Heavy clotting) (seriousness criteria death and medically significant) and INTERCHANGE OF VACCINE PRODUCTS (patient received JANSSEN COVID-19 VACCINE). The patient died on an unknown date. The reported cause of death was Hemorrhage, Heart attack and Clot blood. It is unknown if an autopsy was performed. At the time of death, INTERCHANGE OF VACCINE PRODUCTS (patient received JANSSEN COVID-19 VACCINE) outcome was unknown.            No concomitant product was provided. No treatment information were reported. Causality for JANSSEN as per reporter and mfr. was possible.  Company comment.  This fatal spontaneous case concerns a female patient (unknown age) with no medical history reported, who experienced the unexpected, serious (medically significant and fatal) AESI of myocardial infarction and thrombosis, and the unexpected serious event of haemorrhage. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. The patient received mRNA-1273 vaccine reported as booster vaccination in her COVID  19 vaccination schedule, previously she received a dose of Janssen COVID  19 vaccines (interchange of vaccine products could be considered). The report stated that the patient died of hemorrhaging with heavy clotting and multiple heart attacks. It was unspecified if an autopsy was performed. No further details were provided for medical review. Co  suspect product Janssen COVID  19 vaccine remains as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This fatal spontaneous case concerns a female patient (unknown age) with no medical history reported, who experienced the unexpected, serious (medically significant and fatal) AESI of myocardial infarction and thrombosis, and the unexpected serious event of haemorrhage. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. The patient received mRNA-1273 vaccine reported as booster vaccination in her COVID  19 vaccination schedule, previously she received a dose of Janssen COVID  19 vaccines (interchange of vaccine products could be considered). The report stated that the patient died of hemorrhaging with heavy clotting and multiple heart attacks. It was unspecified if an autopsy was performed. No further details were provided for medical review. Co  suspect product Janssen COVID  19 vaccine remains as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Hemorrhage; Heart attack; clot blood