Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Syncope
Clinical narrative: CEREBROVASCULAR ACCIDENT; SYNCOPE; ACUTE KIDNEY INJURY; DYSSTASIA; BLOOD GLUCOSE INCREASED; BLOOD PRESSURE INCREASED; ASTHENIA; MUSCULAR WEAKNESS; BLOOD TEST; COMPUTERISED TOMOGRAM HEAD ABNORMAL; CONDITION AGGRAVATED; HYPOAESTHESIA; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; This spontaneous report received from a consumer via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and the patient had no history of diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered to right arm on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included enalapril for high blood pressure. On 12-APR-2021, the patient came from work in the morning and complained numbness in left side (hypoesthesia). The patient thought it was related to the weather getting warm and as he works in the night shift, he rested and increased his water intake. He was able to go to work on that night and returned home and continued to rest. On 13-APR-2021, the patient had no numbness, but had weakness in both his legs (muscular weakness). On 14-APR-2021, the patient experienced weakness throughout his body (asthenia), especially in his legs. On 15-APR-2021, the patient collapsed (syncope), he did not lose consciences but his legs gave out under him and he was not able to get up (dysstasia). The patient was taken to the hospital and was diagnosed with a stroke (cerebrovascular accident), increased blood glucose levels, acute kidney injury, and uncontrolled increased blood pressure. During his hospital stay, Blood test (result: not reported), Computerized tomogram head (result: abnormal), and Magnetic resonance imaging head (result: not reported) were performed. The patient was hospitalized for 5 days and was discharged on 19-APR-2021. On 24-APR-2021, the patient experienced another episode of stroke (cerebrovascular accident, condition aggravated) and was readmitted to hospital and Blood test (result: not reported), Computerized tomogram head (result: abnormal) were performed. On an unspecified date, the patient visited emergency department. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute kidney injury, asthenia, blood glucose increased, blood pressure increased, cerebrovascular accident, computerised tomogram head abnormal, condition aggravated, dysstasia, hypoaesthesia, magnetic resonance imaging head abnormal, muscular weakness, syncope, and blood test. This report was serious (Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage).   Version created to amend previously reported information on 07-May-2021. Upon review the following information was amended: Labelling for event MUSCULAR WEAKNESS and ASTHENIA was updated from labeled to unlabeled in Core.; Sender's Comments: V1:20210514642- covid-19 vaccine ad26.cov2.s -Cerebrovascular accident, Syncope, Acute kidney injury, Asthenia, Blood glucose increased, Blood pressure increased, Computerized tomogram head abnormal , Condition aggravated, Dysstasia, Hypoaesthesia, Magnetic resonance imaging head abnormal , Muscular weakness, and Blood test. 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: MEDICAL HISTORY,UNDERLYING DISEASE