Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoxia, Pleural effusion, Pulmonary embolism, SARS-CoV-2 test, Thrombocytopenia
Clinical narrative: DEATH; HYPOXIA; PULMONARY EMBOLISM; PLEURAL EFFUSION; ANGIOGRAM; ATRIAL FIBRILLATION; ULTRASOUND SCAN ABNORMAL; DEEP VEIN THROMBOSIS; ECHOCARDIOGRAM ABNORMAL; ASTHMA; THROMBOCYTOPENIA; CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19; VACCINE BREAKTHROUGH INFECTION; ABDOMINAL PAIN LOWER; DYSPNOEA; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) concerned a 65 year old male of unspecified race and ethnic origin. Initial information was processed along with the additional information received on 19-Nov-2021 and from Central Complaint Vigilance department on 23-Nov-2021. The patient's height and weight were not reported. The patient concurrent conditions include hypertension and type 2 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 to left arm for an unspecified indication. No concomitant medications were reported. On 09-OCT-2021, the patient tested positive for Covid-19 (confirmed clinical vaccination failure). On 20-OCT-2021, the patient was admitted to hospital with worsening shortness of breath and asthma. In emergency room patient presented with ST elevation DKA (diabetic ketoacidosis). Insulin drip protocol was started and patient was taken to lab where 100% LAD (left anterior descending) occlusion was observed and received DES (drug-eluting stent). Later admitted to intensive care unit (ICU) started on remdesivir, Decadron, insulin drip. Continued thrombocytopenia was noted consistent with DIC (disseminated intravascular coagulation) and no "TOCI" given requiring high flow oxygen, transferred out of ICU. On 21-OCT-2021 echocardiogram showed left ventricular ejection fraction (LVEF) 20-25%, DVT (Deep vein thrombosis) ultrasound showed right distal femoral to entire popliteal DVT. The patient was started on enoxaparin. On 23-OCT-2021, the patient developed atrial fibrillation with rapid ventricular response (A fib RVR) and was initially treated with digoxin and then with amiodarone drip, patient developed more shortness of breath and was then transferred to ICU, downgraded to med telemetry on 24-OCT-2021 in early morning. On 24-OCT-2021, chest computed tomography angiogram showed bilateral lower lobe pulmonary emboli consolidations and bilaterally bilateral pleural effusions and was started on Eliquis. The patient required ongoing high flow oxygen need. On 25-OCT-2021 repeat echocardiogram was done with similar results of LVEF of 25%. On 26-OCT-2021 the patient was started on empiric treatment of ceftriaxone and doxycycline. On 28-OCT-2021, patient was transferred to ICU for work of breathing hypoxia intolerant of BiPAP (bilevel positive airway pressure) and was able to come off Bipap in the evening to high flow oxygen, able to take in some through oral. During the course of the night on the same day the patient experienced desaturations despite Bipap. The patient was intubated. Unfortunately, patient expired, PEA (Pulseless electrical activity) arrest later in the morning on 29-OCT-2021. Despite several rounds of cardiopulmonary resuscitation, patient expired at 3:05 am on 29-OCT-2021 from an unknown cause of death. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of from an unknown cause of death on 29-OCT-2021, and the outcome of abdominal pain lower, angiogram, asthma, atrial fibrillation, covid-19, deep vein thrombosis, dyspnoea, echocardiogram abnormal, hypoxia, pleural effusion, pulmonary embolism, thrombocytopenia, ultrasound scan abnormal, vaccine breakthrough infection was fatal and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000203205. 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 Central Complaint Vigilance department on 24-NOV-2021. The following information was updated and incorporated into the case narrative: PQMS number and Product quality complaint investigation result added.; Sender's Comments: V1:Additional information received updates: PQMS number and Product Quality complaint investigation result. This updated information does not alter prior causality assessment of reported events. 20211130291-COVID-19 VACCINE AD26.COV2.S - deep venous thrombosis, thrombocytopenia, pulmonary embolism, ultrasound scan abnormal . This event(s) is labeled per RSI and is therefore considered potentially related.  20211130291-COVID-19 VACCINE AD26.COV2.S -asthma, atrial fibrillation, echocardiogram abnormal, covid-19, vaccine breakthrough infection, death, dyspnoea, hypoxia, pleural effusion, abdominal pain lower, angiogram. 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).  20211130291-COVID-19 VACCINE AD26.COV2.S -confirmed clinical vaccine 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH