Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Angiogram abnormal, Angiogram pulmonary, Angiogram pulmonary abnormal, Anticoagulant therapy
Clinical narrative: HYPOXIA; LYMPHADENOPATHY; PNEUMOTHORAX; TACHYCARDIA; BIOPSY MUSCLE; RIGHT VENTRICULAR DYSFUNCTION; BIOPSY LUNG; RIGHT VENTRICULAR FAILURE; ECHOCARDIOGRAM ABNORMAL; DYSPNOEA; ANGIOGRAM ABNORMAL; PULMONARY HYPERTENSION; HAEMOGLOBIN DECREASED; INGUINAL MASS; THROMBECTOMY; RIGHT VENTRICULAR FAILURE; SARS-COV-2 TEST POSITIVE; RIGHT VENTRICULAR DYSFUNCTION; ECHOCARDIOGRAM ABNORMAL; INGUINAL MASS; MUSCLE MASS; LYMPHADENOPATHY; PELVIC MASS; PELVIC MASS; SINUS ARRHYTHMIA; PULMONARY MASS; BIOPSY LUNG; SINUS ARRHYTHMIA; ANGIOGRAM PULMONARY ABNORMAL; TACHYCARDIA; ANTICOAGULANT THERAPY; MUSCLE MASS; PULMONARY MASS; CARDIAC DISORDER; COVID-19; CONDITION AGGRAVATED; CARDIAC DISORDER; DYSPNOEA; CONDITION AGGRAVATED; ATRIAL FLUTTER; PULMONARY EMBOLISM; PULMONARY EMBOLISM; HAEMOGLOBIN DECREASED; PULMONARY HYPERTENSION; BIOPSY MUSCLE; ATRIAL FIBRILLATION; PNEUMOTHORAX; ANGIOGRAM PULMONARY ABNORMAL; ATRIAL FIBRILLATION; ANTICOAGULANT THERAPY; HYPOXIA; SARS-COV-2 TEST POSITIVE; ANGIOGRAM ABNORMAL; COVID-19; ATRIAL FLUTTER; This spontaneous report received from a health care professional by a Regulatory Authority, Vaccine Adverse Event Reporting System (VAERS) (VAERS ID: 2591807) concerned a 75 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, lung mass, acute respiratory failure with hypoxia, soft tissue mass, and pneumothorax after biopsy, and concurrent conditions included: bilateral pulmonary embolism, acute anemia, acute deep vein thrombosis, DVT (deep vein thrombosis) of left lower extremity, and drug allergy (sulfa and had rash), benign prostatic hyperplasia (BPH), non-smoker, and tobacco user, and other pre-existing medical conditions included: The patient had no history of current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total was administered on 09-APR-2021 for an unspecified indication. Age at time of vaccination 74 years old. Concomitant medications included amiodarone hydrochloride (Pacerone), apixaban (Eliquis), fish oil, omega-3 fatty acids, and tamsulosin hydrochloride (Flomax). On 20-FEB-2023, the patient experienced unspecified symptoms for COVID-19 which had started about 1 week prior to the hospital admission. On 27-FEB-2023, the patient was presented to the emergency department with severe shortness of breath (dyspnoea), bilateral pulmonary embolism, acute pulmonary embolism with acute cor pulmonale of unspecified pulmonary embolism type (pulmonary embolism), The patient had recently started workup for left gluteal maximus mass (muscle mass) and felt to be liposarcoma. On arrival the patient was significantly tachycardiac (tachycardia) (cardiac disorder) with rates up into the 160s appeared to be atrial flutter. The patient required IV (intravenous) diltiazem and after administration and was spontaneously converted back to normal sinus rhythm (sinus arrhythmia). CTA (Computed Tomography Angiography) of thorax (angiogram pulmonary abnormal) was performed which had shown bilateral PE (pulmonary embolism) with right heart strain and multiple pulmonary masses (pulmonary mass). The patient was started on a heparin drip (anticoagulant therapy) . The patient also had a largest mass in the right upper lobe which was most suspicious for neoplasm.  The patient was additionally had COVID-19 positive (sars-cov-2 test positive) (COVID-19). On 28-FEB-2023, the patient had consulted interventional radiologist and completed mechanical thrombectomy which had removed 85-90 percent of clot burden with some improvement in pulmonary hypertension via PA (Pascal) pressures from 40 8 18 to 34 8 16 mmHg (pulmonary hypertension)  Echocardiogram (echocardiogram abnormal) was performed prior to thrombectomy with moderate to severe RV (acute right ventricle) dysfunction (right ventricular dysfunction) and moderate dilation with systolic septal flattening consistent with RV (right ventricular) pressure overload (right ventricular failure). MRI (Magnetic Resonance Imaging) of the left hip was attempted to be obtained, but the patient was unable to tolerate for test and examinations were non diagnostic due to motion artifact. The patient continued to intermittently revert back to atrial flutter.  The patient had later consulted cardiologist where they had initiated intravenous (IV) amiodarone and later the patient had spontaneously converted back to NSR (Normal sinus rhythm) to maintain his sinus rhythm. The patient was transitioned to oral loading dose 3 4 Hemoglobin (haemoglobin decreased) and noted to trend down after procedures with CTA abdomen (angiogram abnormal) and CTA pelvis obtained to rule out retroperitoneal hemorrhage. This demonstrated no active bleed but had shown enlarging left pelvic (pelvic mass) and inguinal masses (inguinal mass) likely enlarging lymph nodes (lymphadenopathy) as well as a prior nodule in the right lower lobe that had grown significantly in size which was already suspicious for aggressive malignancy. On 03-MAR-2023, the patient had biopsy completed for his right upper lobe mass (biopsy muscle) as well as left gluteal mass (biopsy lung) in order to limit interruption of anticoagulation. The patient had very small right apical pneumothorax after the procedure which had improved with conservative management. The patient was evaluated by pulmonary rehabilitation who recommended home oxygen which only needed with activity Hypoxemia (hypoxia) and it was likely not related to COVID as the patient symptoms onset had occurred around 20-FEB-2023. The patient had not started steroids and had to continue 14-day amiodarone load with 400 mg twice per day and then after 14 days 200 mg daily. Upon follow-up with cardiologist, the patient was started on Eliquis and the patient had to continue this as the starter pack after the discharge. The patient was hospitalized for 6 days and on 05-MAR-2023, the patient was discharged from hospital. The drug latency was reported as 689 days. The patient had a follow up with pulmonologist for biopsy results. The patient need to repeat echo and it was reported that the patient would obtain complete blood count within the next 1 week at the time of reporting and the patient needs oncology referral by PCP (primary care physician) once biopsy results were finalized.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulmonary hypertension, atrial fibrillation, hypoxia, pneumothorax, pulmonary embolism, right ventricular dysfunction, right ventricular failure, atrial flutter, covid-19, cardiac disorder, condition aggravated, dyspnoea, inguinal mass, lymphadenopathy, muscle mass, pelvic mass, pulmonary mass, sinus arrhythmia, tachycardia, thrombectomy, anticoagulant therapy, angiogram pulmonary abnormal, angiogram abnormal, haemoglobin decreased, biopsy muscle, biopsy lung, echocardiogram abnormal, and sars-cov-2 test positive. This report was serious (Hospitalization Caused / Prolonged). This case was associated with a product quality complaint 90000275615. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related. Batch and lot tested and found within specifications based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 29-MAR-2023. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: This follow up version updates- Product quality complaint investigation result. This updated information does not alter the causality of previously reported events.  20230349252-pulmonary hypertension, atrial fibrillation, hypoxia, pneumothorax, right ventricular dysfunction, right ventricular failure, atrial flutter, cardiac disorder, condition aggravated, dyspnoea, inguinal mass, lymphadenopathy, muscle mass, pelvic mass, pulmonary mass, sinus arrhythmia, tachycardia, , haemoglobin decreased, biopsy muscle, biopsy lung, echocardiogram abnormal,   pulmonary embolism, thrombectomy, anticoagulant therapy, angiogram pulmonary abnormal, angiogram abnormal. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.  20230349252-sars-cov-2 test positive, covid-19. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.