Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Sepsis, Septic shock, Somnolence
Clinical narrative: DEATH; CARDIAC ARREST; CHEST TUBE INSERTION; THROMBOSIS; ULTRASOUND DOPPLER ABNORMAL; CHEST X-RAY ABNORMAL; LIFE SUPPORT; ATELECTASIS; LUNG OPACITY; SOMNOLENCE; PAIN; COUGH; COVID-19; SARS-COV-2 TEST POSITIVE; OXYGEN SATURATION DECREASED; CONTINUOUS HAEMODIAFILTRATION; BLOOD LACTIC ACID INCREASED; HYPERTENSION; PNEUMOTHORAX; RENAL IMPAIRMENT; SEPTIC SHOCK; SEPSIS; DECREASED APPETITE; This spontaneous report received from a health care professional by a Regulatory Authority (VAERS FDA Inbound Unit 2005918) concerned a 79 year old male of unspecified race and ethnicity. Initial information was processed along with additional information received on 18-JAN-2022. The patient's height, and weight were not reported. The patient's past medical history included: cerebral vascular accident and stroke, and concurrent conditions included: coronary artery disease, gastroesophageal reflux disease, hyperlipidemia, hypertension, restless leg syndrome, and sleep apnea. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1805025 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 08-APR-2021 for an unspecified indication. Concomitant medications included acetylsalicylic acid, amlodipine, atorvastatin, clopidogrel, ferrous sulfate, furosemide, glyceryl trinitrate, isosorbide dinitrate, losartan, metoprolol tartrate, nifedipine, omeprazole, pramipexole, sildenafil, testosterone, tramadol, vitamin b12, and multivitamins.  On Thursday (unspecified date), the patient began to develop achy pains and felt sleepy. When his symptoms did not improve he decided to call his primary care doctor. Patient thought he had a urinary tract infection. On 20-DEC-2021, the patient had SARS-CoV-2 test (NR: not provided) which resulted positive for covid-19. He states since that time he has been monitoring his oxygen saturations on his pulse oximetry at home and his oxygen saturations are dropping below 90%. On 22-DEC-2021, the patient had arrived to the emergency room at 88% on room air. He was requiring 5 Liter nasal cannula to maintain his oxygen saturations greater than 92%. On 22-DEC-2021, the chest X-ray showed areas of patchy opacification in the left mid and lower lung and right lower lung, some of this may be infectious inflammatory such as pneumonia while some of this may be atelectatic. He states that he has had decreased appetite, and non-productive cough. He reports that he took his morning medications. The patient was placed on dexamethasone, ceftriaxone, azithromycin and remdesivir. On 27-DEC-2021, Laboratory data included: Diagnostic ultrasound doppler test (NR: not provided) which was positive for nonocclusive calf vein thrombus right lower extremity posterior tibial and peroneal distributions. On 04-JAN-2021, the patient continued to be hypertensive overnight and required increased pressor therapy. He also had a small right-sided pneumothorax that was treated with a right-sided chest tube on 04-JAN-2021 with resolution of the pneumothorax. He continued to be hemodynamically unstable from the COVID sepsis, septic shock also possible pulmonary embolism with elevated lactate levels. His kidney function worsened and he needed CVVH (Continuous Venovenous Hemofiltration, coded as continuous haemodiafiltration) overnight. In the morning on 04-JAN-2021 the patient had cardiac arrest with ROSC (Return of spontaneous circulation) after 3 cycles of ACLS (Advanced cardiac life support). On 04-JAN-2021, the patient died from an unknown cause of death. The duration of hospitalization was 13 days. It was unknown whether an autopsy was performed. (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause of death on 04-JAN-2021 and the outcome of cardiac arrest, life support, septic shock, sepsis, thrombosis, pneumothorax, oxygen saturation decreased, renal impairment, atelectasis, chest tube insertion, hypertension, lung opacity, somnolence, covid-19, decreased appetite, continuous haemodiafiltration, blood lactic acid increased, chest x-ray abnormal, ultrasound doppler abnormal, sars-cov-2 test positive, cough and pain was fatal. This report was serious (Death, and Hospitalization Caused / Prolonged). This case was associated with Product quality complaint number 90000212626. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 18-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: The follow up information in this version updates Patient's Product quality complaint investigation result. This updated information does not alter the causality of previously reported events.  20220126449- covid-19 vaccine ad26.cov2.s - Death, cardiac arrest, septic shock, sepsis, thrombosis, pneumothorax, renal impairment, atelectasis, life support, decreased appetite, lung opacity, somnolence, pain, cough, covid-19, sars-cov-2 test positive, chest tube insertion, oxygen saturation decreased, continuous haemodiafiltration, blood lactic acid increased, chest x-ray abnormal, ultrasound doppler abnormal. 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).  20220126449-covid-19 vaccine ad26.cov2.s-hypertension. 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: MEDICAL HISTORY.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH