Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Angiogram abnormal, COVID-19, Cerebellar stroke, Computerised tomogram
Clinical narrative: CEREBELLAR STROKE; VERTEBRAL ARTERY OCCLUSION; ANGIOGRAM ABNORMAL; COVID-19; COMPUTERISED TOMOGRAM; MAGNETIC RESONANCE IMAGING HEAD; SARS-COV-2 TEST POSITIVE; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 1981581) concerned a 54 year old male.  Initial information was processed along with additional information received on 10-JAN-2022. The patient's height and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 16-JUN-2021 for an unspecified indication. Drug start period was 187 days. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient received no concomitant medications.  On 20-DEC-2021, the patient tested positive for covid 19 without active respiratory symptoms. On same date, the patient underwent Computerized tomography (CT) and (magnetic resonance imaging head (MRI) brain, computed tomography angiography (CTA) head neck with occlusion of distal left vertebral artery. Laboratory data included: CT angiography (NR: not provided) Angiogram abnormal, Computerized tomography (NR: not provided) Not specified, MRI brain (NR: not provided) Not specified, and SARS-CoV-2 test (NR: not provided) Positive. On 25-DEC-2021, the patient presented with acute left cerebellar stroke. The workup for eitology of stroke ongoing was unclear if due to covid 19 infection. Although less likely caused by J J as the patient got vaccine 6 months prior to the report. The patient visited to an emergency room and physician's office and was hospitalized on unspecified date. Number of days of hospitalization was not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from angiogram abnormal, covid-19, cerebellar stroke, computerised tomogram, magnetic resonance imaging head, sars-cov-2 test positive, and vertebral artery occlusion, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000210982. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from RA on 18-JAN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: Additional information in this version is regarding: Product quality complaint investigation result. This does not alter the company causality of previously reported events 20220112330-Covid-19 vaccine ad26.cov2.s-Cerebellar Stroke, vertebral artery occlusion, angiogram abnormal, covid-19, computerised tomogram, magnetic resonance imaging head, sars-cov-2 test positive. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20220112330-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS