Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram thorax, Computerised tomogram thorax abnormal, Death, Dyspnoea
Clinical narrative: DEATH; CARDIAC ARREST; PULMONARY EMBOLISM; HYPOXIA; COVID-19 INFECTION; LUNG INFILTRATION; ANTICOAGULANT THERAPY; CHEST X-RAY ABNORMAL; COMPUTERISED TOMOGRAM THORAX ABNORMAL; CONTINUOUS POSITIVE AIRWAY PRESSURE; DYSPNOEA; INTENSIVE CARE; MECHANICAL VENTILATION; OXYGEN SATURATION DECREASED; PRODUCTIVE COUGH; TACHYPNOEA; SARS-COV-2 TEST POSITIVE; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority [VAERS FDA Inbound Unit] concerned a 59 year old male unspecified race and ethnicity. Initial information was processed along with the additional information received from Central Complaint Vigilance on 17-Aug-2021 The patient's height, and weight were not reported. The patient's concurrent conditions included: Degenerative joint disease of the spine, hyperlipidemia, obesity, sinus problems, and penicillin allergy. The patient experienced drug allergy when treated with codeine for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 in total administered on 26-FEB-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included acetylsalicylic acid, acetylsalicylic acid/oxycodone hydrochloride/oxycodone terephthalate, desloratadine/pseudoephedrine sulfate, pravastatin and triamcinolone acetonide for drug used for unknown indication.  On 16-JUL-2021, the patient's laboratory data included COVID-19 virus test (NR: not provided) which was positive and had covid-19 infection. On 27-JUL-2021, the patient had lung infiltration, pulmonary embolism, hypoxia, anticoagulant therapy, chest x-ray abnormal, computerized tomogram thorax abnormal, continuous positive airway pressure, dyspnoea, intensive care, mechanical ventilation, oxygen saturation decreased, productive cough, tachypnoea, and was hospitalized. Laboratory data included: chest x-ray(CXR) (NR: not provided) which shown bilateral infiltrate's. On 27-JUL-2021, the patient was admitted in hospital intensive care unit with shortness of breath, productive cough and oxygen saturation on 86%. On 31-JUL-2021, the patient had more shortness of breath and was on continuous positive airway pressure high flow and CT of the chest was done showing pulmonary embolism (PE). Treatment medications included: heparin. The patient was put on heparin drip and was decompensated, was connected to minute volume (MV) and went to cardiac arrest, and the patient had passed at 09:57 on 02-AUG-2021. The cause of death was cardiac arrest. It was unknown if autopsy was performed. The patient was hospitalized for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of cardiac arrest, death, pulmonary embolism, hypoxia, covid-19 infection, lung infiltration, sars-cov-2 test positive, anticoagulant therapy, chest x-ray abnormal, computerised tomogram thorax abnormal, continuous positive airway pressure, dyspnoea, intensive care, mechanical ventilation, oxygen saturation decreased, productive cough and tachypnoea on 02-AUG-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000189962. The suspected product quality complaint has been confirmed to be non voided as the reported allegation could not be confirmed, and 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 13-SEP-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: The follow up adds about  product quality complaint investigation result. This follow up information does not alter the causality of previously reported events. 20210832915-Covid-19 vaccine ad26.cov2.s- Death,cardiac arrest, pulmonary embolism, hypoxia, covid-19 infection, lung infiltration, sars-cov-2 test positive, anticoagulant therapy,chest x-ray abnormal, computerized tomogram thorax abnormal, continuous positive airway pressure, dyspnoea, intensive care, mechanical ventilation, oxygen saturation decreased, productive cough and tachypnoea. This event(s) is considered unassessable. The event(s) has an 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). 20210832915- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination 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: CARDIAC ARREST