Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Chest discomfort, Influenza like illness, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: COVID-19 pneumonia; Pulmonary embolism; COVID-19; Chest discomfort; Influenza like illness; Angiogram pulmonary abnormal; Anticoagulant therapy; Ultrasound Doppler normal; SARS-CoV-2 test positive; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS), (VAERS ID: 1749652) concerned a 56 year old male of unspecified race and ethnic origin. Initial information was processed along with the additional information received on 11-OCT-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: deep vein thrombosis (DVT), and the patient had no known drug allergies. The patient had no other acute issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for an unspecified indication. Concomitant medications included benzonatate. On 26-SEP-2021, the patient experienced covid-19 pneumonia, pulmonary embolism, angiogram pulmonary abnormal, anticoagulant therapy, covid-19, chest discomfort, influenza like illness, sars-cov-2 test positive, ultrasound doppler normal, confirmed clinical vaccination failure. On the same day, the patient was hospitalized. Laboratory data included: Angiogram pulmonary (NR: not provided) Abnormal, SARS-CoV-2 test (NR: not provided) COVID-19 positive, and Ultrasound Doppler (NR: not provided) Normal. On an unspecified date, laboratory data included: Computed Tomography angiography was performed and showed acute nonocclusive pulmonary emboli in the proximal basal segmental branches of the left lower lobe posterior right lower lobe and posterior right upper lobe without right heart strain. Patient was started on heparin infusion. On an unspecified date, Lower extremity ultrasound was performed and did not reveal any evidence of DVT (Deep vein thrombosis). Other acute pulmonary embolism without acute cor pulmonale Pneumonia due to COVID-19 virus. Patient was presented with flu like symptoms and chest tightness was found to be COVID positive but was not hypoxic and did not meet criteria for either Remdesivir or Decadron. The patient continued to remain hemodynamically stable and did not require any oxygen therapy. Care management did check that patient had coverage for Eliquis. The patient was transitioned off heparin drip and placed on Eliquis. The patient continued with Eliquis therapy for acute pulmonary embolism. Treatment medications (dates unspecified) included: heparin, and apixaban. The patient was discharged on 27-SEP-2021, to home in stable condition. The patient was hospitalized for 2 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia, pulmonary embolism, angiogram pulmonary abnormal, anticoagulant therapy, covid-19, chest discomfort, influenza like illness, sars-cov-2 test positive, and ultrasound doppler normal, 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: The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received on 19-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: This follow up adds information about  Product quality complaint investigation result. This does not alter previous causality assessment of the reported events  Covid-19 vaccine ad26.cov2.s -Covid-19 pneumonia,  Pulmonary embolism, Covid-19, Chest discomfort, Influenza like illness, Angiogram pulmonary abnormal,  Anticoagulant therapy, Ultrasound doppler normal,  SARS CoV-2 test positive. 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).  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