DEATH; RENAL DYSFUNCTION; SHOCK; PNEUMONIA RELATED TO PSEUDOMONAS; CYTOMEGALOVIRUS MILD REACTIVATION; CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; COLITIS; MULTIPLE SECONDARY INFECTIONS; This spontaneous report was received from literature. 2021 Nov 10. This report concerned a 7 decade old patient of unspecified race, ethnic origin and sex. The objective of this study emphasizes the need for more conservative precautions to prevent Covid-19 infection in transplant recipients. The patient's height, and weight were not reported. The patient's past medical history included: lung transplantation in 2016, and other pre-existing medical conditions included: The patient had excellent allograft function, no history of recent rejection. The patient was working at correctional facility associated with more than 250 covid-19 cases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mycophenolate mofetil, prednisone, and tacrolimus. It was reported that on an unspecified date after vaccination, sixty-two days later, the patient developed fever, cough, and dyspnea. Admission occurred on day 5 of illness. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) was positive (confirmed clinical vaccination failure). Sequencing identified as Alpha variant. Chest radiograph demonstrated diffuse pulmonary infiltrates. Providers discontinued mycophenolate and prednisone on admission. Despite prompt treatment with dexamethasone and remdesivir, the patient required intubation 3 days after admission and received tocilizumab at that time. After experiencing a series of complications including severe hypoxemia and renal dysfunction requiring dialysis, the patient developed progressively worsening shock on day 16 of illness. Empiric vancomycin and aztreonam were initiated in the setting of a listed penicillin allergy. The patient progressed to require nearly maximal vasopressor support and supplemental oxygen delivery, and the infectious disease team was consulted. Documentation suggested prior carbapenem tolerance, and the patient was transitioned to meropenem, vancomycin, micafungin, and voriconazole. The patient's vasopressor requirement improved dramatically over the course of several hours. Computed tomography (CT) of the chest on day 17 of illness demonstrated diffuse pulmonary infiltrates with a ground-glass predominance and coalescent consolidations. Simultaneous CT of the abdomen demonstrated significant thickening of the sigmoid colon. Despite initial clinical improvement with empiric antimicrobials, the patient sustained a fatal cardiac arrest on day 17 of illness. The patient developed colitis, pneumonia related to pseudomonas, and multiple secondary infections. Purulent secretions from a tracheal aspirate subsequently grew mucoid Pseudomonas aeruginosa and Candida albicans. Blood cultures grew Clostridium innocuum and C albicans. Serum cytomegalovirus (CMV) PCR resulted at 267 IU/mL (cytomegalovirus mild reactivation). Stool PCR for Clostridioides difficile was negative. Qualitative SARS-CoV-2 anti-spike immunoglobulin G (IgG) obtained on day 16 of illness was positive. Semi-quantitative SARS-CoV-2 anti-spike IgG obtained on day 17 of illness was positive, detected at a concentration of 70.4 U/mL. The patient was hospitalized for 13 days and died before nucleocapsid IgG testing was performed. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from renal dysfunction, confirmed covid-19 infection, shock, colitis, pneumonia related to pseudomonas, multiple secondary infections, and cytomegalovirus mild reactivation, and the outcome of confirmed clinical vaccination failure was not reported and on an unspecified date, the patient died from unknown cause of death. The authors concluded that in light of recent trends in the spread of the Delta variant as well as novel variants that may represent the end result of recombination events, this work emphasizes the ongoing importance of more conservative precautions to avoid Covid-19 infection in transplant recipients. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000221709.; Sender's Comments: V0:20220321576-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. 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, Therefore, this event(s) is considered not related. 20220321576-COVID-19 VACCINE AD26.COV2.S- Death, Renal dysfunction, Shock. 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). Therefore, this event(s) is considered unassessable. 20220321576-COVID-19 VACCINE AD26.COV2.S-,Pneumonia related to pseudomonas, Multiple secondary infections,  Confirmed covid-19 infection , Colitis, Cytomegalovirus mild reactivation  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 (Immunocompromised status). Therefore, this event(s) is considered not related; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH