Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Computerised tomogram thorax abnormal, Death, Dyspnoea, Endotracheal intubation
Clinical narrative: PULMONARY EMBOLISM; DEATH; PLATELET DISORDER; ENDOTRACHEAL INTUBATION; DYSPNOEA; HYPOXIA; COMPUTERISED TOMOGRAM THORAX ABNORMAL; This spontaneous report received via health authority VAERS (Vaccine Adverse Event Reporting System)(VAERS ID: 1230024); concerned a 57 year old female, race and ethnicity not reported. The patient's height, and weight were not reported. The patient's medical history included kidney stones, urinary tract infection without hematuria, site unspecified, type 2 diabetes mellitus with diabetic chronic kidney disease, type 2 diabetes with other specified complication, chronic kidney disease, stage II (mild), hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified kidney disease, unspecified heart failure, unspecified hyperlipidemia, atherosclerotic heart disease of native coronary artery without angina pectoris, lower extremity edema, unspecified chronic obstructive pulmonary disease, obstructive sleep apnea (adult, pediatric), unspecified peripheral vascular disease, dilated cardiomyopathy, severe morbid obesity due to excess calories, and nicotine dependence with nicotine-induced disorder. The patient's concurrent condition included bipolar disorder, current episode. No known drug allergy was reported.  The patient, at age of 57, received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient's symptoms included shortness of breath, hypoxia, pulmonary embolism, and intubation death. Laboratory data showed chest CT was with PE and platelets were reported as ' Nl platelets at arrival. Then decrease'. On 04-APR-2021, the subject died from pulmonary embolism, dyspnoea, endotracheal intubation, hypoxia, platelet disorder, and computerised tomogram thorax abnormal. It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 04-APR-2021. This report was serious (Death, and Hospitalization Caused / Prolonged).  Version created to amend previously reported information on 30-APR-2021. Upon review the following information was amended: Medical assessment comment was updated.; Sender's Comments: V1: Follow up amends Brighton Collaboration level of certainty to Level 5.  This case obtained via VAERS (VAERS ID 1230024) concerned a 57-year-old female of unknown race/ethnicity who was hospitalized for pulmonary embolism (PE) with shortness of breath and hypoxia 13 days after receiving the Janssen Covid-19 vaccine. Medical history included type 2 diabetes mellitus with diabetic chronic kidney disease, atherosclerotic heart disease of native coronary artery, heart failure, dilated cardiomyopathy, severe morbid obesity, hyperlipidemia, chronic obstructive pulmonary disease, obstructive sleep apnea, kidney stones, urinary tract infection, peripheral vascular disease, nicotine dependence, lower extremity edema, and bipolar disorder.  CT chest showed PE. Platelets were normal initially, then decreased without a specific platelet value reported (coded to Platelet disorder); further information & other lab test results were not reported. The patient was intubated. The patient died 19 days after vaccine. It was unknown if autopsy was performed. The patient's multiple chronic conditions & obesity may have increased the risk for the pulmonary embolism and death to occur. However, considering the temporal relationship with vaccination (Brighton Collaboration Criteria level 5), a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.; Reported Cause(s) of Death: PULMONARY EMBOLISM; DYSPNOEA; ENDOTRACHEAL INTUBATION; HYPOXIA; PLATELET DISORDER; COMPUTERISED TOMOGRAM THORAX ABNORMAL