Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Echocardiogram, Echocardiogram normal, Ejection fraction, Ejection fraction normal
Clinical narrative: ATRIAL FIBRILLATION; DEEP VEIN THROMBOSIS; COVID-19; SARS-COV-2 TEST POSITIVE; COMPUTERISED TOMOGRAM THORAX NORMAL; ECHOCARDIOGRAM NORMAL; EJECTION FRACTION NORMAL; ANTICOAGULANT THERAPY; This spontaneous report received from a health care professional by a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 2095700) concerned a 62 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 15-MAR-2021 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The drug start period (latency) was 316 days. No concomitant medications were reported. The patient received additional covid-19 vaccine of an unspecified manufacturer (dose number in series 2) (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on 27-OCT-2021 for an unspecified indication. On 25-JAN-2022, the patient was admitted through the emergency room because of sudden onset of atrial fibrillation with rapid ventricular response (RVR).  On admission to the hospital, the patient had tested positive for covid-19 and was also diagnosed with deep vein thrombosis. The patient was started initially on intravenous drip of diltiazem (Cardizem) and was then switched to short acting diltiazem (Cardizem) for 6 hours. The patient had remained in normal sinus rhythm. Cardiology consultation was made. The patient was also on apixaban (Eliquis) (anticoagulant therapy). Laboratory data included: Computerized tomogram thorax (NR: not provided) normal, Echocardiogram (NR: not provided) normal, Ejection fraction (NR: not provided) normal, and SARS-CoV-2 test (NR: not provided) positive. On an unspecified date in JAN-2022, Laboratory data included: CT (computerized tomogram) chest (NR: not provided) no evidence of acute PE (pulmonary embolism) and no acute process, and 2 dimensional (2D) Echocardiogram (NR: not provided) no abnormality with EF (ejection fraction) over 50%. The patient was hospitalized for 3 days and was discharged home. (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anticoagulant therapy, atrial fibrillation, covid-19, computerized tomogram thorax normal, deep vein thrombosis, echocardiogram normal, ejection fraction normal and sars-cov-2 test positive was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is associated with a product quality complaint: 90000218251. 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 was received from Complaint Department on 08-MAR-2022. The following information was updated and incorporated into case narrative: product quality complaint investigation result was added.; Sender's Comments: V1: Additional information received is regarding product quality complaint investigation result. The follow up information received does not alter the assessment of prior company causality of previously reported events. : 20220243821-covid-19 vaccine ad26.cov2.s-Atrial fibrillation, deep vein thrombosis, covid-19, anticoagulant therapy, computerized tomogram thorax normal, echocardiogram normal, ejection fraction normal and sars-cov-2 test positive. 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). Therefore, this event(s) is considered unassessable.