Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Condition aggravated, Dyspnoea, Pulmonary embolism, Pulmonary infarction
Clinical narrative: COVID-19 PNEUMONIA; PULMONARY INFARCTION; PULMONARY EMBOLISM; TACHYCARDIA; COVID-19; CONDITION AGGRAVATED; SARS-COV-2 TEST POSITIVE; ANTICOAGULANT THERAPY; COMPUTERISED TOMOGRAM THORAX ABNORMAL; DYSPNOEA; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System), concerned an 85 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: abnormal CT (computerized tomography) of the chest, and hip hemiarthroplasty (surgical procedure), and concurrent conditions included: hyperlipidemia, benign essential hypertension, peripheral arterial occlusive disease, HCC (Hepatocellular carcinoma was diagnosed in 2016), osteoarthritis, esophageal adenocarcinoma, dyspnea, chronic obstructive pulmonary disease (unspecified type), tobacco abuse (in remission), diffusion capacity of lung (decreased), dysphagia, esophageal cancer (carcinoma stage 3), closed right hip fracture, multiple lung nodules (first noted in FEB-2021, with most suspicious 6 mm RUL (unspecified)), gastroesophageal reflux disease (unspecified whether esophagitis present), non-healing surgical wound-hip right anterior (On 14-OCT-2021 office visit with wound care), autoimmune hemolytic anemia, pulmonary embolism, pulmonary infarction, penicillin allergy (Hives), and DM2 (Type II diabetes mellitus). The patient had previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose and start therapy date were not reported, dose series 1 administered for an unspecified indication. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: Unknown) dose was not reported, 1 in total administered on 30-OCT-2021 for an unspecified indication. Age at time of vaccination 85 years old. Concomitant medications included apixaban, paracetamol, salbutamol, salbutamol sulfate, and vitamin b complex. On 22-JUL-2022, the patient found to be tachycardic (tachycardia) and was short of breath (dyspnoea) (Dose number in series: 2) in oncology office, and was found to be positive for COVID (covid-19 and SARS-CoV-2 test Positive) (Dose number in series: 2) in the ER (emergency room) and CT scan showed bilateral PEs (pulmonary embolism). On the same day, the patient presented with covid-19 pneumonia, bilateral PE (pulmonary embolism) (Dose number in series: 2) and was admitted to the hospital. On the same day, the patient also experienced pulmonary infarction and condition aggravated (Dose number in series: 2). The patient was started on a heparin drip (anticoagulant therapy) (Dose number in series: 2) and increased doses of steroids. Laboratory data included: Computerised tomogram thorax Abnormal, and SARS-CoV-2 test Positive. It was reported that the patient improved symptomatically and was not hypoxic. The patient was transitioned from heparin to Eliquis (anticoagulant therapy). The patient was hospitalized for 3 days, and was doing well (no short of breath and his vitals were normal) at the time of discharge. On 25-JUL-2022, the patient was discharged in stable condition.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia, pulmonary embolism, pulmonary infarction, tachycardia, dyspnoea, covid-19, condition aggravated, anticoagulant therapy, computerised tomogram thorax abnormal, and sars-cov-2 test positive. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000246565. 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 department on 07-SEP-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: This follow-up version updates: Product quality complaint investigation result. The prior causality assessment remains unaltered with this information. 20220829628- covid-19 vaccine ad26.cov2.s- pulmonary embolism, pulmonary infarction, dyspnea, anticoagulant therapy, computerized tomogram thorax abnormal. The case causality is considered NOT RELATED. Rationale: The medical history of the patient -pulmonary embolism, pulmonary infarction, carcinomas provide more plausible explanation for these events.  20220829628- covid-19 vaccine ad26.cov2.s  covid-19 pneumonia, sars-cov-2 test positive, tachycardia, covid-19, condition aggravated. 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.