Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tracheostomy
Clinical narrative: This spontaneous report received from a health care professional by a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS-US-VAERS-2032598-EHRR-20220121125256) concerned a 70 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, diabetes mellitus, and hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: unknown) dose was not reported, 1 total administered on 18-MAR-2021 for an unspecified indication. Drug start period was 260 days. Concomitant medications included atorvastatin calcium, citalopram hydrobromide, dorzolamide hydrochloride and glipizide for drug used for unknown indication. On 02-DEC-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On 03-DEC-2021, patient presented to Emergency Room for COVID-19 pneumonia with acute hypoxic respiratory failure with Acute respiratory distress syndrome (ARDS) and admitted. On 03-DEC-2021, acute respiratory failure, aspiration, atrial fibrillation, bacteremia, Covid-19 pneumonia, deep vein thrombosis, intensive care unit delirium, pneumonia, septic shock, anticoagulant therapy, atrial flutter, Covid-19, candida test positive, cardioversion, chest x-ray abnormal, endotracheal intubation, gastrostomy, hypotension, intensive care unit acquired weakness, Klebsiella test positive, mechanical ventilation, sars-cov-2 test positive, superinfection, tracheal aspirate culture, tracheostomy. After that, on 23-DEC-2021, the patient was treated with Remdesivir and course of Decadron. The patient required prolonged intubation and mechanical ventilation and was subsequently trached and pegged. Hospital course was complicated by superimposed ventilator associated pneumonia with tracheal cultures growing Klebsiella species. The patient also grew Candida parapsilosis in the blood was treated with a course of cefepime and initially fluconazole subsequently switched to IV (Intravenous) micafungin from 23-DEC-2021. Patient had septic shock at some point and required pressors Bacteremia was resolved. Patient had been followed by pulmonology Critical Care. Patient also did develop bilateral upper extremity Deep vein thrombosis (DVT) and was treated with full-dose Lovenox. Later on patient developed Atrial fibrillation (AFib) with hypotension and following Cardiology evaluation was started on an amiodarone drip. On 02-JAN-2022, patient was cardioverted due to persistent hypotension and eventually converted to sinus rhythm transition to p o amiodarone and metoprolol. Patient had remained on ventilator via tracheostomy and got daily weaning trials that remained on 35% FiO2. From 10-JAN-2022, patient continued to had increased tracheal aspirate and repeat tracheal cultures again grew Klebsiella species. On 11-JAN-2021, patient was resumed on IV cefepime switched to Rocephin 1gram IV daily to 7 days and micafungin 100 mg BID to continue for 7 more days ended on 20-JAN-2021. Patient also had critical illness myopathy due to long hospitalization steroid and paralytic use and had received physical therapy. Patient had ICU delirium as well was started on Seroquel which was very helpful. Patient was hemodynamically stable. On 13-JAN-2022, patient was discharged to Long-term acute care (LTAC) to continue aggressive physical therapy and ventilator management. Patient was hospitalized from 03-DEC-2021 to 13-JAN-2022 (41 days). Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. On 04-DEC-2021, Laboratory data included: Chest X-ray (NR: not provided) Diffuse bilateral pneumonias. On 23-DEC-2021, Laboratory data included: Candida test (NR: not provided) growth, and Klebsiella test (NR: not provided) positive. On 29-DEC-2021, treatment medications included: micafungin. Treatment medications included: remdesivir. Additional treatment medications (dates unspecified) included: cefepime hydrochloride, levofloxacin, dexamethasone, and fluconazole, amiodarone, metoprolol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute respiratory distress syndrome, acute respiratory failure, aspiration, atrial fibrillation, bacteremia, Covid-19 pneumonia, deep vein thrombosis, intensive care unit delirium, pneumonia, septic shock, anticoagulant therapy, atrial flutter, Covid-19, candida test positive, cardioversion, chest x-ray abnormal, endotracheal intubation, gastrostomy, hypotension, intensive care unit acquired weakness, Klebsiella test positive, mechanical ventilation, sars-cov-2 test positive, superinfection, tracheal aspirate culture, and tracheostomy. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000213701. 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 18-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result was added. Sender's Comments: V1: Additional information received during follow up updates: Product quality complaint investigation result. This updated information does not alter the causality of previously reported events. 20220142136-COVID-19 VACCCINE AD26.COV2.S-Acute respiratory distress syndrome, Acute respiratory failure,- Aspiration, Atrial fibrillation, Bacteremia, Covid-19 pneumonia, Deep vein thrombosis, Intensive care unit delirium, Pneumonia, Septic shock, Anticoagulant therapy, Atrial flutter, Covid-19, Candida test positive, Cardioversion, Chest X-ray abnormal, Endotracheal intubation, Gastrostomy, Hypotension, Intensive care unit acquired weakness, Klebsiella test positive, Mechanical ventilation,SARS-COV2-test-positive,Superinfection,Tracheal aspirate culture, Tracheostomy. 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).