Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Cough, Fibrin D dimer, Fibrin D dimer increased, Gallbladder disorder
Clinical narrative: ATYPICAL PNEUMONIA; BLOOD TEST ABNORMAL; NEPHROLITHIASIS; SARS-COV-2 TEST POSITIVE; PULMONARY EMBOLISM; FIBRIN D DIMER INCREASED; ATELECTASIS; BLOOD TEST ABNORMAL; COVID-19; COVID-19; MALAISE; CHILLS; ASTHENIA; MALAISE; PNEUMONITIS; ASTHENIA; PULMONARY EMBOLISM; BODY TEMPERATURE INCREASED; CHILLS; CHOLELITHIASIS; BODY TEMPERATURE INCREASED; COUGH; GALLBLADDER DISORDER; LEUKOCYTOSIS; LEUKOCYTOSIS; NASOPHARYNGITIS; NASOPHARYNGITIS; RESPIRATORY TRACT CONGESTION; PNEUMONITIS; ANGIOGRAM PULMONARY ABNORMAL; RESPIRATORY TRACT CONGESTION; COMPUTERISED TOMOGRAM THORAX ABNORMAL; SARS-COV-2 TEST POSITIVE; ANTICOAGULANT THERAPY; ANGIOGRAM PULMONARY ABNORMAL; ATYPICAL PNEUMONIA; FIBRIN D DIMER INCREASED; GALLBLADDER DISORDER; COMPUTERISED TOMOGRAM THORAX ABNORMAL; CHOLELITHIASIS; ANTICOAGULANT THERAPY; NEPHROLITHIASIS; This spontaneous report received from a health care professional via Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 2329187) concerned a 75 year old male of unspecified race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes mellitus type ii, hypertension, coronary artery disease, and obstructive sleep apnea, and other pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date was not reported) dose was not reported, 1 total administered on 01-APR-2021 for an unspecified indication. Age at time of vaccination 75 years old. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included acetylsalicylic acid, apixaban, atorvastatin, glimepiride, insulin glargine, metformin, nifedipine, and salbutamol. On 03-JAN-2022, the patient experienced anticoagulant therapy, asthenia, atelectasis, atypical pneumonia, body temperature increased. covid-19, chills, cholelithiasis, cough, gallbladder disorder, leukocytosis, malaise, nasopharyngitis, nephrolithiasis, pneumonitis, pulmonary embolism, respiratory tract congestion. On the same day, patient had angiogram pulmonary abnormal, anticoagulant therapy, blood test abnormal, computerised tomogram thorax abnormal, fibrin d dimer increased, sars-cov-2 test positive. It was reported that On 03-JAN-2022, patient comes to ED (emergency department) complaining of not feeling well. Patient states that for the past 2 weeks has been feeling sick. Initially it started as cold and chills.  Complains of feeling congested with mild cough which was nonproductive but denies chest pain or shortness of breath. Patient had been feeling progressively weak.  He took a home COVID-19 test and tested positive. On 5-JAN-2022, He received monoclonal antibody infusion. Patient noted his oxygen saturation was below 90 could not get it about 90 which prompted him to come to the ED. Patient states he was taking ever make 10 and hydroxychloroquine prophylactically before he tested positive and also for a few days after the positive test. In the ED his temp was 100 8° F, pulse ox was 89% on room air and now on 3 L oxygen by NC saturating 94% , blood work was significant for leukocytosis and elevated D-dimer, CT angio chest was done and was reported as right middle lobe pulmonary embolism without right heart strain diffuse pneumonitis atypical pneumonia versus sub segmental atelectasis. CT chest (Computerized tomogram thorax) also reported bilateral renal pelvic nephrolithiasis cholelithiasis with distended gallbladder and findings concerning for exophytic dorsal right posterior liver lobe neoplasia. On 20-JAN-2022, Patient was given IV ceftriaxone and Zithromax in the ED anticoagulation with Lovenox. The patient also given zinc sulfate, vitamin-C and vitamin-D, Eliquis 10 mg bd for 7 days then 5 mg twice a day afterwards. Patient also continued on home metformin and glimepiride, azithromycin course, Decadron course Hemodynamically stable for discharge. It was reported that patient will discharge home and follow up with PCP in 3-5 days and Patient agrees with plan. The patient was hospitalized for 4 days.  Laboratory data included: Angiogram pulmonary Abnormal, Blood test Abnormal, Body temperature Increased, Computerised tomogram thorax right middle lobe pulmonary embolism without right heart strain diffuse pneumonitis atypical pneumonia versus subsegmental atelectasis, Fibrin D Dimer Increased, and SARS-CoV-2 test Positive. On 05-JAN-2022, treatment medications included: edrecolomab. On 20-JAN-2022, treatment medications included: azithromycin, ceftriaxone, and levofloxacin. On 22-JUN-2022, Laboratory data included: Oxygen saturation Below 90. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.8 F, CT scan bilateral renal pelvic nephrolithiasis cholelithiasis with distended gallbladder and findings concerning for exophytic dorsal right posterior liver lobe neoplasia, and Pulse oximetry (NR: not provided) 89 %.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from angiogram pulmonary abnormal, anticoagulant therapy, asthenia, atelectasis, atypical pneumonia, blood test abnormal, body temperature increased, covid-19, chills, cholelithiasis, computerised tomogram thorax abnormal, cough, fibrin d dimer increased, gallbladder disorder, leukocytosis, malaise, nasopharyngitis, nephrolithiasis, pneumonitis, pulmonary embolism, respiratory tract congestion, and sars-cov-2 test positive. This report was serious (Hospitalization Caused / Prolonged).  Version created to amend previously reported information on 02-JUL-2022. Upon review the following information was amended: Amendment Narrative (batch number statement added in narrative).; Sender's Comments: V1: This version updates: batch number statement added in narrative. The prior causality assessment of reported events remains unaltered . 20220705648-covid-19 vaccine ad26.cov2.s- atypical pneumonia, nephrolithiasis, asthenia, atelectasis,  blood test abnormal, body temperature increased, covid-19, chills, cholelithiasis,  cough, gallbladder disorder, leukocytosis, malaise, nasopharyngitis, pneumonitis, respiratory tract congestion, 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.  20220705648-covid-19 vaccine ad26.cov2.s-pulmonary embolism, Angiogram pulmonary abnormal, Fibrin D dimer increased, Computerised tomogram thorax abnormal, Anticoagulant therapy. This event(s) is labeled per RSI and is therefore considered potentially related.