Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Endotracheal intubation, Intensive care, Pulmonary embolism
Clinical narrative: ACUTE RESPIRATORY FAILURE; ENDOTRACHEAL INTUBATION; INTENSIVE CARE; SARS-COV-2 TEST POSITIVE; COVID-19; PULMONARY EMBOLISM; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2055433) on 04-FEB-2022 and concerned an 83 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: anxiety, Benign prostatic hyperplasia (BPH) with obstruction, depression, dysphagia, hypertension, Gastrooesophageal reflux disease (GERD) and paroxysmal atrial fibrillation no anticoagulation. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: unknown) dose was not reported, 1 total administered on left arm on 11-MAR-2021 for unspecified indication. Drug start period was 307 days. Concomitant medications included acetylsalicylic acid, clonazepam, duloxetine, finasteride, guaifenesin, mecobalamin, metoprolol, mirtazapine, olanzapine, pantoprazole, paracetamol, sennoside a+b, tamsulosin, tramadol, and trazodone. On 12-JAN-2022, the patient tested positive for COVID (sars-cov-2 test positive) and was hospitalized (date unspecified). The patient was admitted to inpatient (intensive care) intubated (endotracheal intubation) with acute hypoxemic respiratory failure due to COVID-19 and pulmonary embolism. The patient was hospitalized for 9 days. As of 21-JAN-2022, the patient was still in hospital.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute respiratory failure, endotracheal intubation, intensive care, pulmonary embolism, sars-cov-2 test positive and covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged).  This report was associated with product quality complaint: 90000216455. 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 11-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.This updated information does not alter the causality of previously reported events. 20220213293- covid-19 vaccine ad26.cov2.s- acute respiratory failure,pulmonary embolism, endotracheal intubation, intensive care,  sars-cov-2 test positive and covid-19. 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).