Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke, Rhabdomyolysis, Ultrasound Doppler, Ultrasound Doppler abnormal
Clinical narrative: CAROTID ARTERY THROMBOSIS; CEREBRAL ARTERY THROMBOSIS; CEREBRAL MASS EFFECT; CEREBROVASCULAR ACCIDENT; RHABDOMYOLYSIS/LIKELY TRAUMATIC RHABDOMYOLYSIS; ISCHEMIC STROKE; ULTRASOUND DOPPLER; ULTRASOUND DOPPLER ABNORMAL; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS reference number 1293926), in addition to information received from literature. This report concerned a 71 year old female. The objective of this study was to research is needed to better understand the underlying patho-mechanism and to investigate whether subcutaneous injection of vaccines may be able to prevent rhabdomyolysis. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperlipidemia, and neuropathy. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN and expiry: UNKNOWN) dose was not reported, 1 total administered on 05-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 gabapentin, and simvastatin. On 03-MAY-2021 (3-4 weeks after receiving the COVID vaccine), the patient presented with right middle cerebral artery (MCA) stroke with mass effect (cerebral mass effect), mild midline shifts and right middle cerebral artery thrombus (cerebral artery thrombosis) and carotid ultrasound showed thrombosis (carotid artery thrombosis) of the right common and internal carotid arteries and right carotid siphon. On the same day that is 28 days after vaccination the patient also experienced ischemic stroke. The reporter reports that the patient was found down last seen normal 2 days prior to admission, and also reports that the patient was not a good candidate for tissue plasminogen activator (tPA) given the delayed presentation and unlikely to benefit from thrombus extraction and the patient was hospitalized (date unspecified) for 4 days. The patient was treated with aspirin (acetylsalicylic acid) and atorvastatin and treated for rhabdomyolysis. The reporter also reports that the patient was currently still admitted to the hospital but transitioning to comfort focused care. The patient had no acute kidney failure. Laboratory data (dates unspecified) included: Ultrasound Doppler and Ultrasound Doppler was abnormal, and peak creatine kinase level which was unknown.  As per the report, the patient was recovered with permanent disability from the events ischemic stroke, likely traumatic rhabdomyolysis following vaccination with Ad26.COV2.S. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from ischemic stroke, and rhabdomyolysis/likely traumatic rhabdomyolysis, and had not recovered from carotid artery thrombosis, cerebral artery thrombosis, cerebral mass effect, cerebrovascular accident, ultrasound doppler, and ultrasound doppler abnormal. The authors emphasized on physicians should be aware of the possibility of vaccine-induced rhabdomyolysis as a potentially serious side-effect in patients particularly in times of mass vaccinations. Patients may be advised to monitor the color of their urine for the early detection of rhabdomyolysis. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage). This case, from Literature article is linked to 20210721677, 20210924327, 20210922624 and 20210922810. 20210923039, 20210639871, 20210914711, 20210528129, 20210528518, 20210705289, 20210702722, 20210757800, 20210762171, 20210905291, 20210923028, 20210922823, 20210705289, and 20210923042.  Additional information was received from literature on 07-SEP-2021 and from Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS reference number 1293926) on 13-SEP-2021. The following information was updated and incorporated into the case narrative: This case considered as literature. Additional reporters were added, additional event (Ischemic stroke - seriousness hospitalization and disability) was added, the RRT of the event was updated from rhabdomyolysis to rhabdomyolysis/likely traumatic rhabdomyolysis and the outcome was changed from not recovered/not resolved to recovered/resolved with sequelae, additional lab data (Peak creatine kinase level) was added, and narrative description was updated.; Sender's Comments: V1: This follow up adds- Additional reporters, additional event (Ischemic stroke - seriousness hospitalization and disability), the RRT of the event was updated from rhabdomyolysis to rhabdomyolysis/likely traumatic rhabdomyolysis and the outcome was changed from not recovered/not resolved to recovered/resolved with sequelae, additional lab data (Peak creatine kinase level) and narrative description. 20210543394-covid-19 vaccine ad26.cov2.s  Ischemic stroke, Cerebrovascular accident.  Follow-up received regarding Clinical Details. This event(s) is considered unassessable. The event(s) has a 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). 20210543394-covid-19 vaccine ad26.cov2.-Rhabdomyolysis/likely traumatic rhabdomyolysis.  Follow-up received regarding Other Information: RRT updated. This event(s) is considered unassessable. The event(s) has a 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). 20210543394-covid-19 vaccine ad26.cov2.s-Carotid artery thrombosis, Cerebral artery thrombosis, Cerebral mass effect, Ultrasound doppler, Ultrasound doppler abnormal. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.