Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Computerised tomogram, Investigation, SARS-CoV-2 test
Clinical narrative: positive for SARS-CoV-2; positive for SARS-CoV-2; This is a literature report for the following literature source(s).  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hepatitis B virus (HBV)" (unspecified if ongoing); "hepatitis C virus (HCV)" (unspecified if ongoing); "cirrhosis" (unspecified if ongoing); "simultaneous orthotopic liver transplant" (unspecified if ongoing); "cadaveric renal transplant" (unspecified if ongoing); "renal cell carcinoma" (unspecified if ongoing); "partial nephrectomy" (unspecified if ongoing); "chronic kidney disease" (unspecified if ongoing); "Kaposi sarcoma of right forearm" (unspecified if ongoing), notes: on radiation therapy; "right upper extremity deep vein thrombosis" (unspecified if ongoing); "benign prostatic hyperplasia" (unspecified if ongoing); "transurethral resection of the prostate" (unspecified if ongoing); "latent tuberculosis infection" (unspecified if ongoing); "cytomegalovirus (CMV)" (unspecified if ongoing); "pneumocystis jirovecii pneumonia (PJP)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Tozinameran (Dose 1), for covid-19 immunization; Tozinameran (Dose 2), for covid-19 immunization. The following information was reported: VACCINATION FAILURE (death, hospitalization, medically significant), COVID-19 (death, hospitalization, medically significant), all with latency 2 months after the suspect product(s) administration, outcome "fatal" and all described as "positive for SARS-CoV-2". The patient underwent the following laboratory tests and procedures: Body temperature: 39.3 Centigrade; Computerised tomogram: innumerable 1-2mm nodules in a miliary pattern, notes: throughout the lungs, mild splenomegaly, and abdominopelvic lymphadenopathy; (1,3)-ß-D-glucan: 69 pg/mL; SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient date of death was unknown. Reported cause of death: "disseminated histoplasmosis", "haemodynamic instability", "positive for SARS-CoV-2".  Clinical courses: A 64-year-old man developed disseminated histoplasmosis following immunosuppressant therapy with tacrolimus, mycophenolate, and prednisone. Additionally, he exhibited lack of efficacy with tozinameran as COVID-19 immunisation, remdesivir for SARS-CoV-2 infection, and with amphotericin-B-liposomal and posaconazole for disseminated histoplasmosis [routes and duration of treatment to reaction onset not stated; not all dosages stated]. The man with a history of hepatitis B virus (HBV) and hepatitis C virus (HCV) cirrhosis, underwent a simultaneous orthotopic liver transplant and cadaveric renal transplant. His immunosuppression regimen included tacrolimus, mycophenolate, and prednisone. Five years after his transplantation, he presented with ten days of cough, sore throat, fever, chills, pleuritic chest pain, and progressive dyspnoea. Two days prior to presentation, he was positive for SARS-CoV-2. He had received tozinameran [Pfizer mRNA SARSCoV 2 vaccine] 0.3mL, two months prior to the current illness. Past medical history included renal cell carcinoma with partial nephrectomy, chronic kidney disease, Kaposi sarcoma of right forearm on radiation therapy, right upper extremity deep vein thrombosis, benign prostatic hyperplasia with transurethral resection of the prostate, latent tuberculosis infection, HBV with undetectable viral load on tenofoviralafenamide, and HCV. Two years after his transplant, he had cytomegalovirus (CMV) and pneumocystis jirovecii pneumonia (PJP). On admission, he received three days of remdesivir for 3 days, but remained persistently febrile with a temperature of 39.3 degree centigrade. Further investigations were done, wherein (1,3)-ß-Dglucan was 69 pg/mL, and a CT scan revealed innumerable 1-2mm nodules in a miliary pattern throughout the lungs, mild splenomegaly, and abdominopelvic lymphadenopathy. Based on this, a diagnosis of disseminated histoplasmosis infection was made. The man was then started on amphotericin-B-liposomal [liposomal-amphotericin B], which was later switched to posaconazole. However, he ultimately developed abdominal pain and distension with haemodynamic instability and died on hospital day 51 due to disseminated histoplasmosis and haemodynamic instability. Since he developed SARS-CoV-2 despite receiving tozinameran, and no improvement was seen with remdesivir, amphotericin-B-liposomal and posaconazole, lack of efficacy with tozinameran, remdesivir, amphotericin-B-liposomal and posaconazole were thus considered.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: positive for SARS-CoV-2; disseminated histoplasmosis; haemodynamic instability