Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Haemorrhagic stroke, Ischaemic stroke
Clinical narrative: hemorrhagic stroke; ischemic stroke; This spontaneous case was reported by a patient and describes the occurrence of ISCHAEMIC STROKE (ischemic stroke) and HAEMORRHAGIC STROKE (hemorrhagic stroke) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (dose 2) and Pfizer (dose 1). Past adverse reactions to the above products included No adverse effect with Pfizer and Pfizer.  On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ISCHAEMIC STROKE (ischemic stroke) (seriousness criteria hospitalization and medically significant). In 2023, the patient experienced HAEMORRHAGIC STROKE (hemorrhagic stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from sometime in December 2021 to sometime in December 2021 due to ISCHAEMIC STROKE. At the time of the report, ISCHAEMIC STROKE (ischemic stroke) and HAEMORRHAGIC STROKE (hemorrhagic stroke) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: abnormal. On an unknown date, Blood pressure measurement: abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no known drug allergy. No pertinent medical history. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. It was reported that on 20th Dec 2021, he suffered an ischemic stroke. He was hospitalized for 3 days and after discussing with HCPs post-hospital stay there might have been some underlying health factors. Those factors were weight, the fact that he was graduating at the time, the pressure of university and the psychological effects of the pandemic. He also states that he was not paying attention to his health at the time and he had a fear of getting COVID. He was put on blood pressure and cholesterol medications as well as blood thinners at the time. He states that he started recovering and his numbers were starting to get normal so his doctor took him off the cholesterol medications. He was finally off the blood pressure and cholesterol medications. At this time it was 14 months from the original stroke and he suffered an hemorrhagic stroke. Reporter causality was not reported.  Company comment:  This is a spontaneous case concerning a 23-year-old male patient with no reported medical history, who experienced the serious (due to medically significant and hospitalization) unexpected, AESI events of ischaemic stroke and haemorrhagic stroke. The event ischaemic stroke occurred 13 days after a dose of mRNA-1273 vaccine, received as the third dose of COVID-19 vaccination schedule. The event haemorrhagic stroke occurred approximately 14 months after vaccination. Patient received doses 1 and 2 with Pfizer COVID-19 vaccine. It was reported that on 20th Dec 2021, he suffered an ischemic stroke. He was hospitalized for 3 days and after discussing with HCPs post-hospital stay there might have been some underlying health factors. Those factors were weight, the fact that he was graduating at the time, the pressure of university and the psychological effects of the pandemic. He also states that he was not paying attention to his health at that time, and he had a fear of getting COVID. He was put on blood pressure and cholesterol medications as well as blood thinners at the time. He states that he started recovering and his numbers were starting to get normal, so his doctor took him off the cholesterol medications. He was finally off the blood pressure and cholesterol medications. At this time, it was 14 months from the original stroke, and he suffered a hemorrhagic stroke. The outcome of the event was reported as recovered with sequelae. Event haemorrhagic stroke was assessed as not related due to lack of temporal relationship (too long latency). Ischaemic stroke, as well as interruption of blood pressure and cholesterol medications could be a risk factor for haemorragic stroke. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.