Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Fall, Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: Got a brain bleed; started falling multiple times a day,Started falling, patient fell; In the brain, he was having little/mini ischemic strokes (Dysarthria, Balance disorder, Gait disturbance and Cognitive disorder); This spontaneous case was reported by a consumer and describes the occurrence of ISCHAEMIC STROKE (In the brain, he was having little/mini ischemic strokes (Dysarthria, Balance disorder, Gait disturbance and Cognitive disorder)), CEREBRAL HAEMORRHAGE (Got a brain bleed) and FALL (started falling multiple times a day,Started falling, patient fell) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 011A21A) for COVID-19 prophylaxis.     The patient's past medical history included Short-term memory loss (Short term memory problems even before the 1st dose for about 2 years.). Concurrent medical conditions included Seasonal allergy.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ISCHAEMIC STROKE (In the brain, he was having little/mini ischemic strokes (Dysarthria, Balance disorder, Gait disturbance and Cognitive disorder)) (seriousness criteria death and medically significant), CEREBRAL HAEMORRHAGE (Got a brain bleed) (seriousness criteria death, hospitalization and medically significant) and FALL (started falling multiple times a day,Started falling, patient fell) (seriousness criterion death). The patient was hospitalized for 3 days due to CEREBRAL HAEMORRHAGE. The patient died on 24-Sep-2021. The reported cause of death was Ischemic stroke, Hemorrhage brain, Slurred speech, Balance difficulty, Gait disturbance, Falling and Cognitive disturbance. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2021, Magnetic resonance imaging: little/mini ischemic strokes in the brain Little/Mini ischemic strokes in the brain (Lungs were clear, carotid arteries were clear, but, in the brain, he was having "little/mini ischemic strokes).         No Concomitant Medication provided. The patients slurred speech worsened within 4 to 5 hours, started having balance and gait issues and was leaning to the right and his balance was off and from that day forward, he started falling multiple times a day. The doctors did MRI to see if he was clotting, lungs were clear, carotid arteries were clear but, in the brain, he was having "little/mini ischemic strokes". Patient started having balance issues, he started falling and there was decline in cognitive function, decline in slurred speech, decline in balance. Eventually the patient fell and got a brain bleed and was hospitalized for the brain bleed as he was in ICU for 3 days and then was discharged to skilled nursing facility. Patient had treated with memory medication.   Company Comment: This is a Spontaneous case concerning a 79-year-old male patient, with relevant medical history of short-term memory loss, who experienced the unexpected, fatal AESIs of Cerebral haemorrhage (also seriousness criteria of hospitalization) and Ischaemic stroke, and the unexpected and fatal event of Fall. Within 4 to 5 hours after the second dose of mRNA-1273 vaccine, the patient's slurred speech worsened, he started having balance and gait issues and was leaning to the right. His balance was off and from that day forward, he started falling multiple times a day. MRI was performed and showed that lungs were clear, carotid arteries were clear but, in the brain, he was having "little/mini ischemic strokes". Once started having balance issues, he started falling and there was decline in cognitive function, decline in slurred speech, decline in balance. Eventually the patient fell and got a brain bleed and was hospitalized as he was in ICU for 3 days and then was discharged to skilled nursing facility. Patient´s death occurred approximately 5 months and 2 weeks after the second dose of mRNA-1273 vaccine. The reported cause of death was ischemic stroke, hemorrhage brain and falling. It is unknown if an autopsy was performed. Patient´s elderly age, as well as relevant medical history of short-term memory loss, could be confounders for Ischaemic stroke, which could be a contributory factor for patient´s fall and consequent cerebral haemorrhage. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-585136 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 79-year-old male patient, with relevant medical history of short-term memory loss, who experienced the unexpected, fatal AESIs of Cerebral haemorrhage (also seriousness criteria of hospitalization) and Ischaemic stroke, and the unexpected and fatal event of Fall. Within 4 to 5 hours after the second dose of mRNA-1273 vaccine, the patient's slurred speech worsened, he started having balance and gait issues and was leaning to the right. His balance was off and from that day forward, he started falling multiple times a day. MRI was performed and showed that lungs were clear, carotid arteries were clear but, in the brain, he was having "little/mini ischemic strokes". Once started having balance issues, he started falling and there was decline in cognitive function, decline in slurred speech, decline in balance. Eventually the patient fell and got a brain bleed and was hospitalized as he was in ICU for 3 days and then was discharged to skilled nursing facility. Patient´s death occurred approximately 5 months and 2 weeks after the second dose of mRNA-1273 vaccine. The reported cause of death was ischemic stroke, hemorrhage brain and falling. It is unknown if an autopsy was performed. Patient´s elderly age, as well as relevant medical history of short-term memory loss, could be confounders for Ischaemic stroke, which could be a contributory factor for patient´s fall and consequent cerebral haemorrhage. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Ischemic stroke; Hemorrhage brain; Slurred speech; Balance difficulty; Gait disturbance; Falling; Cognitive disturbance