Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Death, Inappropriate schedule of product administration
Clinical narrative: Violent behavior; death from natural cause; First Primary monovalent dose on 06MAR2021 2nd Primary monovalent dose on 27MAY2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (death from natural cause) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21A and 004C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mental impairment (He was crazy).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 06MAR2021 2nd Primary monovalent dose on 27MAY2021). On an unknown date, the patient experienced AGGRESSION (Violent behavior). The patient died on 26-Mar-2023. The cause of death was not reported. An autopsy was not performed. At the time of death, AGGRESSION (Violent behavior) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 06MAR2021 2nd Primary monovalent dose on 27MAY2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient died of natural causes. Reporter stated that Moderna vaccine was causing all kinds of problems. Patient had violent episodes prior to his death. No treatment details were reported. Company comment This spontaneous case concerns a 70-year-old male patient with no relevant medical history reported, who received 4 doses of mRNA-1273 and experienced the serious, medically significant, fatal, unexpected event of death and the non-serious event of violent behavior. Death occurred almost 1 year after the 4th dose of mRNA-1273. Violent behavior occurred on an unknown date. The primary doses were received with an interval of approximately 2 months between the 2 doses, therefore, inappropriate schedule of product administration was considered as an additional event. The patient afterwards received the two booster doses. It was reported that the patient died of natural causes and had violent episodes prior to his death. Since the event death occurred almost 1 year after the 2nd booster dose and it was reported that it was due to natural causes, therefore, the causality was considered as not related. No further clinical information was provided for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Reported Cause(s) of Death: died of natural causes