Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Transient ischaemic attack
Clinical narrative: cardiac arrest; his wife had a mini stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CARDIAC ARREST (cardiac arrest) and TRANSIENT ISCHAEMIC ATTACK (his wife had a mini stroke) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax (Dose 1). Past adverse reactions to the above products included No adverse event with Spikevax.    On 20-Nov-2023, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced TRANSIENT ISCHAEMIC ATTACK (his wife had a mini stroke) (seriousness criteria death, hospitalization and medically significant). On 26-Nov-2023, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from sometime in November 2023 to sometime in November 2023 due to TRANSIENT ISCHAEMIC ATTACK, and then on 26-Nov-2023 due to CARDIAC ARREST. The patient died on 26-Nov-2023. The reported cause of death was Cardiac arrest. An autopsy was not performed.            Patient was healthy as per reporter. As reporter remember patent did not had any previous illness nor patient was taking any medicines.  Patient receives other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that Two days after she had a mini stroke and was rushed to a hospital but then transferred to another hospital. She was discharged or released to that hospital without any test.  On 26Nov2023, she was again not feeling well. She had chest pain that turned into chest pressure and get severe and started crying and saying she was going to die,  and immediately she was put in an ambulance however she died due to cardiac arrest as announced by the hospital.  Treatment information was not provided. Company Comment: This is a spontaneous case concerning a 69-year-old female patient with no reported medical history, who experienced the serious (due to medically significant and hospitalization), Fatal, unexpected, events of cardiac arrest and transient ischaemic attack  (AESI) Event transient ischaemic attack occurred approximately 2 days after the a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine, received as the second dose of COVID-19 vaccination schedule. Event cardiac arrest and death occurred 6 days after vaccination. It was reported that two days after vaccination she had a mini stroke and rushed to a hospital. Then she was transferred to another hospital. She was discharged from that hospital without any test. Six days after vaccination, she was again not feeling well. She had chest pain that turned into chest pressure and got severe, and started crying and saying she was going to die. She was immediately put on an ambulance. However, she died due to cardiac arrest as announced by the hospital. The reported cause of death was Cardiac arrest. An autopsy was not performed. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this   This case was linked to US-MODERNATX, INC.-MOD-2024-760502 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-760502:Husband case; Reported Cause(s) of Death: Cardiac Arrest