Age: 81.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Myalgia
Clinical narrative: patient was having a stroke/experienced a massive blood clot in the brain/severely paralyzed from her left side/she began to slur her speech/they were about to have dinner when his wife mentioned she could not see the table; out of breath; headaches coming and going; muscle pain; fatigue every day; cardio respiratory arrest; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (patient was having a stroke/experienced a massive blood clot in the brain/severely paralyzed from her left side/she began to slur her speech/they were about to have dinner when his wife mentioned she could not see the table), DYSPNOEA (out of breath) and CARDIO-RESPIRATORY ARREST (cardio respiratory arrest) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) on 27-Feb-2021, Moderna COVID-19 Vaccine (Dose 2) on 16-May-2021 and Moderna COVID-19 Vaccine (1st booster) on 16-May-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 21-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced CEREBROVASCULAR ACCIDENT (patient was having a stroke/experienced a massive blood clot in the brain/severely paralyzed from her left side/she began to slur her speech/they were about to have dinner when his wife mentioned she could not see the table) (seriousness criteria death, hospitalization and medically significant) and DYSPNOEA (out of breath) (seriousness criteria death and hospitalization). In November 2022, the patient experienced CARDIO-RESPIRATORY ARREST (cardio respiratory arrest) (seriousness criteria death and medically significant). On an unknown date, the patient experienced HEADACHE (headaches coming and going), MYALGIA (muscle pain) and FATIGUE (fatigue every day). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Muscle pain, at an unspecified dose and frequency. The patient died on 11-Nov-2022. The reported cause of death was cardio respiratory arrest, patient was having a stroke/experienced a massive blood clot in the brain/severely paralyzed from her left side/she began to slur her speech/they were about to have dinner when his wife mentioned she could not see the table and out of breath. An autopsy was performed, but no results were provided. At the time of death, HEADACHE (headaches coming and going), MYALGIA (muscle pain) and FATIGUE (fatigue every day) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received 1st dose of Moderna vaccine on 27-Feb-2021, 2nd dose of Moderna vaccine on 16-May-2021 and 1st booster dose on 16-May-2022.  After receiving the bivalent booster on 21-Oct-2022, patient experienced headaches coming and going, muscle pain during a couple of days, and fatigue every day. Patient took Tylenol. On 02-Nov-2022, caregiver explained they were about to have dinner when his wife mentioned she could not see the table, and was out of breath, she began to slur her speech, and the lady beside her who was a nurse stated his wife was having a stroke, they called an ambulance and 15 minutes later they went to the hospital. Doctors mentioned she experienced a massive blood clot in the brain and administered a pill to break it, but it did not work, they tried to catheterized her twice unsuccessfully, and patient became severely paralyzed from her left side, doctors mentioned she would not get much better after this, and caregiver took the decision to let her die. Patient died 9 days later at 10 am on 11-Nov-2022 in a hospice.  On an unknown date, unspecified lab test was performed, no relevant results reported.  Company Comment: This fatal spontaneous case concerns an 81-year-old female patient, with no reported medical history, who experienced the unexpected and serious (death, hospitalization and medically significant) events of CEREBROVASCULAR ACCIDENT, DYSPNOEA and CARDIO-RESPIRATORY ARREST, among other non-serious events, and die after the second booster dose of mRNA-1273.222 vaccine. She experienced headaches coming and going, muscle pain during a couple days, and fatigue every day, and she took paracetamol. Having dinner twelve days after vaccination, she mentioned she could not see and being out of breath, and she began to slur her speech. She was transferred to hospital where a massive blood clot in her brain was found. She received an unknown oral medication and two unsuccessful catheterizations treatment. She became severely paralyzed from her left side. Since she was not going to improve, her caregiver took the decision to let her die. Patient died 9 days later (21 days after vaccination). The reported cause of death was cardiorespiratory arrest, cerebrovascular accident and dyspnoea. An autopsy was performed, but no results were provided. No further clinical information was available for medical review. Patient´s age could be a risk factor for cerebrovascular accident. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Sender's Comments: This fatal spontaneous case concerns an 81-year-old female patient, with no reported medical history, who experienced the unexpected and serious (death, hospitalization and medically significant) events of CEREBROVASCULAR ACCIDENT, DYSPNOEA and CARDIO-RESPIRATORY ARREST, among other non-serious events, and die after the second booster dose of mRNA-1273.222 vaccine. She experienced headaches coming and going, muscle pain during a couple days, and fatigue every day, and she took paracetamol. Having dinner twelve days after vaccination, she mentioned she could not see and being out of breath, and she began to slur her speech. She was transferred to hospital where a massive blood clot in her brain was found. She received an unknown oral medication and two unsuccessful catheterizations treatment. She became severely paralyzed from her left side. Since she was not going to improve, her caregiver took the decision to let her die. Patient died 9 days later (21 days after vaccination). The reported cause of death was cardiorespiratory arrest, cerebrovascular accident and dyspnoea. An autopsy was performed, but no results were provided. No further clinical information was available for medical review. Patient´s age could be a risk factor for cerebrovascular accident. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Reported Cause(s) of Death: cardio respiratory arrest; patient was having a stroke/experienced a massive blood clot in the brain/severely paralyzed from her left side/she began to slur her speech/they were about to have dinner when his wife mentioned she could not see the table