Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Echocardiogram, Echocardiogram abnormal, Ejection fraction
Clinical narrative: This spontaneous report received from a patient via a Regulatory Authority (Vaccine Adverse Event Reporting System) concerned a 62 year old male with unspecified race, and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was on prostate supplement. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: unknown) dose was not reported, one total, administered at right arm, on 20-AUG-2021 for an unspecified indication. Concomitant medications included colecalciferol for drug used for unknown indication. The patient felt like had low lung capacity and felt short of breath (dyspnoea), Increasing shortness of breath every since. Generally the patient was very active. On 02-NOV-2021, the patient was hospitalized, experienced pulmonary embolism, mitral valve incompetence, cardiac dysfunction, dyspnea, emphysema, tachycardia, covid-19, right ventricular systolic pressure decreased, confirmed clinical vaccination failure, echocardiogram abnormal, left ventricular dilatation, ejection fraction decreased, angiogram pulmonary abnormal, sars-cov-2 test positive, cardiac monitoring, lymphadenopathy mediastinal and Zio patch was placed and was unable to obtain records Laboratory data included: Angiogram pulmonary normal, CT scan (NR: not provided) 13:18 impression Small left upper lobe pulmonary embolism non occlusive, emphysema with mildly prominent mediastinal lymph nodes, mildly prominent heart with evidence of decreased right cardiac function, Cardiac monitoring (NR: not provided) not reported, Echocardiogram (NR: not provided) abnormal, Ejection fraction (NR: not provided) decreased, The left ventricle was moderately dilated. The visually estimated ejection fraction was less than 20 percent. The left atrial volume index measured 39 ml m2. Normal right ventricular chamber size. There was moderately reduced right ventricular systolic function. The aortic valve was trileaflet. The leaflets were thin with normal excursion. There was no significant stenosis or regurgitation. There was mild mitral valve regurgitation. The pericardium appeared normal. Right ventricular systolic pressure (NR: not provided) decreased, and SARS-CoV-2 test positive (NR: not provided) positive. The number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from angiogram pulmonary abnormal, covid-19, cardiac dysfunction, dyspnoea, echocardiogram abnormal, ejection fraction decreased, emphysema, left ventricular dilatation, lymphadenopathy mediastinal, mitral valve incompetence, pulmonary embolism, right ventricular systolic pressure decreased, sars-cov-2 test positive, tachycardia, cardiac monitoring, and confirmed clinical vaccination failure. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000202589. 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 from RA department on 22-Nov-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. Upon review following information was amended: medically confirmed field updated.; Sender's Comments: V1: Follow up information in this version updated: Product quality complaint investigation result. Upon review following information was amended: medically confirmed field updated. The follow up information does not change the causality of the previous reported events   20211131298 -covid-19 vaccine ad26.cov2.s- Angiogram pulmonary abnormal, covid-19, cardiac dysfunction, dyspnoea, echocardiogram abnormal, ejection fraction decreased, emphysema, left ventricular dilatation, mitral valve incompetence, pulmonary embolism, right ventricular systolic pressure decreased, sars-cov-2 test positive, tachycardia, cardiac monitoring. 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). 20211131298 -covid-19 vaccine ad26.cov2.s- lymphadenopathy mediastinal. This event(s) is labeled per RA and is therefore considered potentially related. 20211131298 - covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.