Age: 37.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 37-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 4782591) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis and Blood pressure high.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 08-Apr-2022, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). In 2022, CEREBROVASCULAR ACCIDENT (Stroke) had resolved with sequelae.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. On 08-Apr-2022, the patient had a stroke that affected his right side. He was recovering at time of report. The physician had approved him to continue with next scheduled dose of Skyrizi on 16-Jun-2022. He stated that stroke was related to history of high blood pressure. He did not believed that stoke had anything to with SKYRIZI, and was recovering from stroke.The reporter's causality for the event of stroke with Risankizumab Solution for Injection had no reasonable possibility.It was unknown if patient was enrolled in COVID-19-Vaccine Trial.Treatment information was not provided. Company Comment:  This spontaneous case concerns a 37 year old male patient with relevant medical history of Hypertension , Plaque Psoriasis with  reported Co-suspect non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis, .who experienced Serious ( medically significant ) , unexpected, AESI of cerebrovascular accident ( Stroke ) . This event occurred with  vaccination with an unknown dose number of mRNA-1273 vaccine. The onset latency of the event cannot be assessed since the date of vaccination was not provided. The patient's  stroke  affected his right side. No treatment medications , results of laboratories/diagnostic procedures were reported. The patient's physician had approved him to  continue with the next scheduled  Skyrizi and  stated that stroke was related to  the patient's history of high blood pressure and  didn't believed that stoke had anything to with SKYRIZI. Outcome of the event Cerebrovascular Accident  was reported as resolved with sequelae. Event was reported as possibly related to the mRNA-1273 vaccine  by the reporter. The current medical history of Hypertension is considered as confounder for the event Cerebrovascular accident. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 37 year old male patient with relevant medical history of Hypertension , Plaque Psoriasis with  reported Co-suspect non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis, .who experienced Serious ( medically significant ) , unexpected, AESI of cerebrovascular accident ( Stroke ) . This event occurred with  vaccination with an unknown dose number of mRNA-1273 vaccine. The onset latency of the event cannot be assessed since the date of vaccination was not provided. The patient's  stroke  affected his right side. No treatment medications , results of laboratories/diagnostic procedures were reported. The patient's physician had approved him to  continue with the next scheduled  Skyrizi and  stated that stroke was related to  the patient's history of high blood pressure and  didn't believed that stoke had anything to with SKYRIZI. Outcome of the event Cerebrovascular Accident  was reported as resolved with sequelae. Event was reported as possibly related to the mRNA-1273 vaccine  by the reporter. The current medical history of Hypertension is considered as confounder for the event Cerebrovascular accident. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.