Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Embolic stroke, Hyperlipidaemia
Clinical narrative: hyperlipidemia; embolitic stroke; This spontaneous case was reported by a patient and describes the occurrence of EMBOLIC STROKE (embolitic stroke) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019D21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu vaccine (Sep/Oct-2021) in 2021. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Allergy to antibiotic (allergic to cipro drugs), Sulfonamide allergy (allergic to sulfa drugs) and Prehypertension. Concomitant products included AMLODIPINE and LISINOPRIL for Prehypertension.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced EMBOLIC STROKE (embolitic stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERLIPIDAEMIA (hyperlipidemia). The patient was treated with EVOLOCUMAB (REPATHA) in October 2021 for Hyperlipidemia, at a dose of 2 times a week every other week. At the time of the report, EMBOLIC STROKE (embolitic stroke) and HYPERLIPIDAEMIA (hyperlipidemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 130/68 was his baseline and 150/68 if without medication. On an unknown date, Blood test: unremarkable and hyperlipidemia.         The patient had the first embolitic stroke a month after the second dose. At that time, he was out of state and he survived it without being taken to a hospital. The patient stated that before the shot, his blood works were excellent but after the shot he had hyperlipidemia for which he took Repetha Injectable 2x a week every other week starting Oct-2021.  The patient never had COVID positive test or diagnosis.  Company Comment: This spontaneous case concerns a 70-year-old, male patient with relevant current condition of prehypertension treated with combination anti-hypertensives who experienced the unexpected, serious (medically significant) adverse event of special interest Embolic stroke which occurred approximately one month after receiving the second dose of mRNA-1273. The first dose of mRNA-1273 was administered 28 days before the second dose. The clinical presentation of the event was not provided but it was reported that patient has survived the event without the need for hospitalization. Patient's advanced age, concurrent pre-hypertension and hyperlipidaemia are risk factors for embolic stroke. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-612571, MOD-2022-612576 (Patient Link).; Sender's Comments: This spontaneous case concerns a 70-year-old, male patient with relevant current condition of prehypertension treated with combination anti-hypertensives who experienced the unexpected, serious (medically significant) adverse event of special interest Embolic stroke which occurred approximately one month after receiving the second dose of mRNA-1273. The first dose of mRNA-1273 was administered 28 days before the second dose. The clinical presentation of the event was not provided but it was reported that patient has survived the event without the need for hospitalization. Patient's advanced age, concurrent pre-hypertension and hyperlipidaemia are risk factors for embolic stroke. The benefit-risk relationship of mRNA-1273 is not affected by this report.