Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure inadequately controlled, Blood pressure measurement, Cerebral thrombosis, Chest X-ray, Computerised tomogram
Clinical narrative: Cerebral blood clot; Right sided ischemic stroke due to cerebral blood clot; Unstable blood pressure/ Blood pressure inadequately controlled; Moderna Covid19 vaccine 01 Mar 2021 and Janssen Covid19 Vaccine 10 Mar 2021; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL THROMBOSIS (Cerebral blood clot), ISCHAEMIC STROKE (Right sided ischemic stroke due to cerebral blood clot) and BLOOD PRESSURE INADEQUATELY CONTROLLED (Unstable blood pressure/ Blood pressure inadequately controlled) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Plaque psoriasis.    Non-Tobacco user. No illicit drug use.  Previously administered products included for Atopic dermatitis: DUPIXENT. Past adverse reactions to the above products included No adverse event with DUPIXENT. Family history included Stroke. Concurrent medical conditions included Seafood allergy, Alcohol use (Alcohol user/ One to two drinks three to seven days per week/ Beer, wine, mixed drinks/ Moderate drinker.), Shellfish allergy (Shell fish allergy manifested with nausea and vomit occasionally.) and Fruit allergy (Kiwi fruit allergy manifested with horrible rashes and itching.). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] from an unknown date to 31-Oct-2021 for Anticoagulant therapy, COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) from 10-Mar-2021 to 10-Mar-2021 for COVID-19 vaccination, SIMVASTATIN from an unknown date to 31-Oct-2021 for Cholesterol, MELATONIN and COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. In June 2021, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram. In September 2021, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced CEREBRAL THROMBOSIS (Cerebral blood clot) (seriousness criteria hospitalization and medically significant) and ISCHAEMIC STROKE (Right sided ischemic stroke due to cerebral blood clot) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced BLOOD PRESSURE INADEQUATELY CONTROLLED (Unstable blood pressure/ Blood pressure inadequately controlled) (seriousness criterion medically significant) and INTERCHANGE OF VACCINE PRODUCTS (Moderna Covid19 vaccine 01 Mar 2021 and Janssen Covid19 Vaccine 10 Mar 2021). The patient was hospitalized from 29-Oct-2021 to 30-Oct-2021 due to CEREBRAL THROMBOSIS and ISCHAEMIC STROKE. The patient was treated with ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol and Prophylaxis, at a dose of Unknown; LOSARTAN for Blood pressure management, at a dose of Unknown; HEPARIN at a dose of Unknown; TPA at a dose of Unknown and ASPIRIN [ACETYLSALICYLIC ACID] (oral) from 29-Oct-2021 to 31-Oct-2021 for Anticoagulant therapy, at an unspecified dose and frequency. On 30-Oct-2021, CEREBRAL THROMBOSIS (Cerebral blood clot) had resolved. On 31-Oct-2021, ISCHAEMIC STROKE (Right sided ischemic stroke due to cerebral blood clot) had resolved. At the time of the report, BLOOD PRESSURE INADEQUATELY CONTROLLED (Unstable blood pressure/ Blood pressure inadequately controlled) and INTERCHANGE OF VACCINE PRODUCTS (Moderna Covid19 vaccine 01 Mar 2021 and Janssen Covid19 Vaccine 10 Mar 2021) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Chest X-ray: stroke (abnormal) Stroke. On 29-Oct-2021, Computerised tomogram: abnormal (abnormal) Confirmed stroke right side.. On 30-Oct-2021, Magnetic resonance imaging: abnormal (abnormal) Confirmed stroke right side.. On an unknown date, Blood pressure measurement: unstable (abnormal) Unstable. On an unknown date, Electrocardiogram: result not provided Result not provided. On an unknown date, Magnetic resonance imaging: normal (normal) MRI showed clot buster resolved the right side clot. Blood clot dispersed. and result not provided Result not provided.          Patient had therapy of Vitamins from 24-May-2021 to 23-May-2021. The patient received booster COVID vaccine and after six days of receiving vaccine he had a stroke where his left face was sagging, and his speech also started slurring and the acute onset of these symptoms prompted him to go to the emergency room. He received various treatment in the emergency room, including tissue plasminogen activator blood clot buster. He was initially placed in the neuro intensive care unit for two days and was hospitalized for three days from 29October2021 to 31October2021 because of right-sided ischemic stroke due to cerebral blood clot. He had no residual effects. Treatment medication aspirin was given as blood thinner at 325 mg in neuro intensive care unit via oral. He was 95 percent fine upon discharge. He was not prescribed physical therapy.  He also had an implantable cardioverter defibrillator implanted from Apr-2022 to check for atrial fibrillation. On 16March2022, he was implanted with a cardiac monitor to look for atrial fibrillation which was not found evident during his two-weeks of wearing a patch monitor. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded. Laboratory investigations performed included two unspecified biopsies before starting SKYRIZI and genetic testing whose results were not provided.  Company comment: This spontaneous case reported by consumer concerns a 63-year-old male patient, with relevant concomitant use of Risankizumab for plaque psoriasis and simvastatin for cholesterol, and with family history of stroke, who experienced the unexpected, serious (hospitalization and medically significant) AESI cerebral thrombosis and AESI ischemic stroke, around 6 days after receiving a booster dose of mRNA1273; with blood pressure inadequately controlled on unknown date. He had sagging of the left side of the face with slurred speech. Computerised tomography and magnetic resonance imaging of the brain confirmed a stroke on the right side. At the emergency room, he received tissue plasminogen activator then was admitted to neurologic ICU for 2 days. He was also treated with aspirin, rosuvastatin, losartan and heparin. Repeat magnetic resonance imaging of the brain showed resolution of the clot on the right side. He was 95 percent fine upon discharge. The concomitant use of Risankizumab could be a confounding factor for the events. The patient's age and gender, family history of stroke, and history of high cholesterol could be risk factors for the cerebral thrombosis and ischemic stroke. In addition, the patient previous received a different Covid19 vaccine Janssen (interchange of vaccine products). The benefit risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow up received included patient demographics, medical history, event information, suspect drug information, concomitant drug information, treatment drug information, past drug information and laboratory/diagnostic procedures. On 09-May-2022: Follow up received included patient details, medical history, event information, suspect drug information, treatment drug information, past drug information, laboratory/diagnostic procedures, and narrative description. Added seriousness criteria. On 18-May-2022: Follow up received included patient demographics.; Sender's Comments: This spontaneous case reported by consumer concerns a 63-year-old male patient, with relevant concomitant use of Risankizumab for plaque psoriasis and simvastatin for cholesterol, and with family history of stroke, who experienced the unexpected, serious (hospitalization and medically significant) AESI cerebral thrombosis and AESI ischemic stroke, around 6 days after receiving a booster dose of mRNA1273; with blood pressure inadequately controlled on unknown date. He had sagging of the left side of the face with slurred speech. Computerised tomography and magnetic resonance imaging of the brain confirmed a stroke on the right side. At the emergency room, he received tissue plasminogen activator then was admitted to neurologic ICU for 2 days. He was also treated with aspirin, rosuvastatin, losartan and heparin. Repeat magnetic resonance imaging of the brain showed resolution of the clot on the right side. He was 95 percent fine upon discharge. The concomitant use of Risankizumab could be a confounding factor for the events. The patient's age and gender, family history of stroke, and history of high cholesterol could be risk factors for the cerebral thrombosis and ischemic stroke. In addition, the patient previous received a different Covid19 vaccine Janssen (interchange of vaccine products). The benefit risk relationship of mRNA-1273 is not affected by this report.