Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Embolic stroke, Hyperlipidaemia
Clinical narrative: Embolitic stroke; Hyperlipidemia; 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 no. 003F21A) 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/Oct2021) in 2021. Past adverse reactions to the above products included No adverse effect with Flu Vaccine. Concurrent medical conditions included Allergy to antibiotic (Cipro), Drug allergy (Sulfa drugs) and Hypertension (Pre-Hypertension). Concomitant products included AMLODIPINE and LISINOPRIL for Hypertension.    On 15-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EMBOLIC STROKE (Embolitic stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HYPERLIPIDAEMIA (Hyperlipidemia). The patient was hospitalized from 25-Mar-2022 to 28-Mar-2022 due to EMBOLIC STROKE. The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency; ROSUVASTATIN in April 2022 for Hyperlipidemia, at a dose of 10 milligram once a day; EVOLOCUMAB (REPATHA) in October 2021 at a dose of 2x a week every other week and Surgery (T-CAR on his right carotid artery) for Embolic stroke. At the time of the report, EMBOLIC STROKE (Embolitic stroke) had resolved with sequelae 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 is his baseline and 150/68 if without medication. On an unknown date, Blood test: Excellent.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took all the four doses of Moderna vaccine. He experienced 2nd Embolic stroke after 5 weeks of 1st booster dose. He went to ER on 24-Mar-2022. He underwent T-CAR surgery in Mar-2022. He never had a COVID + test or diagnosis and hadn't experienced a similar event in the past. At the time of report it was reported as patient still has deficits from the stroke (after the 2nd stroke) he has some memory deficits, loss of balance, weakness in his legs, and tremors in both hands.  Company comment: This spontaneous case concerns a 70-year-old, male patient with relevant medical history of Hypertension and past drug history of administration of two doses of the mRNA-1273 vaccine, who experienced the unexpected, serious (hospitalization and medically significant) AESI of embolic stroke and an associated unexpected, non-serious event. It was reported that a month after receiving the second dose of the mRNA-1273 vaccine, the patient experienced an embolic stroke (first stroke). No consultation was done and the outcome of the event was unknown. No further details were provided. It was reported that the patient experienced an embolic stroke (second stroke) 5 weeks after receiving the third dose (first booster dose) of the mRNA-1273 vaccine. Approximately 2 months after receiving the third dose, the patient sought consultation at the Emergency room. No details were provided including diagnostic test/s and treatment. However, the following day, the patient was subsequently admitted. He stayed in the hospital for 4 days and underwent a Transcarotid Artery Revascularization (TCAR) surgery in his right carotid artery. It was also reported that the patient still has deficits from the stroke. He experienced some memory deficits, loss of balance, weakness in his legs, and tremors in both hands. The report also stated that prior to vaccination, the patient's blood works (unspecified) were 'excellent' but after receiving the vaccine, he had hyperlipidemia. Laboratory test results were not provided. The patient was prescribed with Plavix (clopidogrel), aspirin, and rosuvastatin 10 mg once daily starting on an unspecified date in Apr2022. The medical history of Hypertension, which is a risk factor for stroke, remains a confounder for the event embolic stroke. The past drug history of administration of two doses of the mRNA-1273 vaccine, with adverse event of embolic stroke after the second dose, also remains a confounder for the event embolic stroke. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Of note, the patient also received the fourth dose (second booster dose) of the mRNA-1273 vaccine and it was reported that the patient experienced a third embolic stroke 6 days after receiving the vaccine. This is further described in the linked case MOD-2022-612576.    This case was linked to MOD-2022-612532, MOD-2022-612576 (Patient Link).; Sender's Comments: This spontaneous case concerns a 70-year-old, male patient with relevant medical history of Hypertension and past drug history of administration of two doses of the mRNA-1273 vaccine, who experienced the unexpected, serious (hospitalization and medically significant) AESI of embolic stroke and an associated unexpected, non-serious event. It was reported that a month after receiving the second dose of the mRNA-1273 vaccine, the patient experienced an embolic stroke (first stroke). No consultation was done and the outcome of the event was unknown. No further details were provided. It was reported that the patient experienced an embolic stroke (second stroke) 5 weeks after receiving the third dose (first booster dose) of the mRNA-1273 vaccine. Approximately 2 months after receiving the third dose, the patient sought consultation at the Emergency room. No details were provided including diagnostic test/s and treatment. However, the following day, the patient was subsequently admitted. He stayed in the hospital for 4 days and underwent a Transcarotid Artery Revascularization (TCAR) surgery in his right carotid artery. It was also reported that the patient still has deficits from the stroke. He experienced some memory deficits, loss of balance, weakness in his legs, and tremors in both hands. The report also stated that prior to vaccination, the patient's blood works (unspecified) were 'excellent' but after receiving the vaccine, he had hyperlipidemia. Laboratory test results were not provided. The patient was prescribed with Plavix (clopidogrel), aspirin, and rosuvastatin 10 mg once daily starting on an unspecified date in Apr2022. The medical history of Hypertension, which is a risk factor for stroke, remains a confounder for the event embolic stroke. The past drug history of administration of two doses of the mRNA-1273 vaccine, with adverse event of embolic stroke after the second dose, also remains a confounder for the event embolic stroke. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Of note, the patient also received the fourth dose (second booster dose) of the mRNA-1273 vaccine and it was reported that the patient experienced a third embolic stroke 6 days after receiving the vaccine. This is further described in the linked case MOD-2022-612576.