Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Cerebrovascular accident, Transient ischaemic attack
Clinical narrative: Mini-stroke; Mini-stroke; Stroke; Blood pressure was high; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), the second episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) and the first episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stenosis. Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN 81) and EVOLOCUMAB (REPATHA) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 09-Mar-2021, the patient experienced the first episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) (seriousness criteria hospitalization and medically significant). On 10-May-2021, the patient experienced the second episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was high). The patient was hospitalized from 06-Mar-2021 to 07-Mar-2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with NITROGLYCERIN on 10-Mar-2021 for Hypertension, at a dose of 1 dosage form. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), the last episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) and BLOOD PRESSURE INCREASED (Blood pressure was high) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 06March2021 he was taken to the hospital by ambulance where he was diagnosed with having had a stroke. He was discharged home on 07March2021.  The evening of 09March2021 he had a mini-stroke but remainded at home.  Early morning on 10March2021 he had another mimi-stroke and was taken to the emergency room by ambulance.  Patient states his blood pressure was high and he thinks he was treated with nitroglyercin but cannot recall the names of other meds given.  He was discharged from the emergency room later that night of 10March2021.  Patient declines to give me his full list of daily meds because that are too many  Company Comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Other contributing factors were reported (concomitant disease).   This case was linked to MOD-2021-209430 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Other contributing factors were reported (concomitant disease).