Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Death
Clinical narrative: covid 19; Death; This is a literature report, Program ID: (005851) for the following literature source(s): "Severe COVID pneumonia and undetectable B cells after vaccination in patients previously treated with rituximab a case series", Postgrad-Med, 2022; Vol:134(2), pgs:239-243.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "smoker" (unspecified if ongoing), notes: Patient was a was a former smoker (27 pack years); "ankylosing spondylitis and ILD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal"; COVID-19 (hospitalization), outcome "unknown", described as "covid 19". The patient underwent the following laboratory tests and procedures: Body mass index: 19.6. The patient date of death was unknown. Reported cause of death: "death". It was not reported if an autopsy was performed.Clinical course; In a case series involving 3 men aged 63-69 years developed undetectable B-cells during treatment with rituximab, prednisone or mycophenolate for interstitial lung disease (ILD), ankylosing spondylitis or pauci-immune glomerulonephritis. They also exhibited lack of efficacy following vaccination with Tozinameran, elasomeran or COVID-19-vaccine-Pfizer-BioNTech for COVID-19 pneumonia. Additionally, they received off-label treatment with dexamethasone, Convalescent-anti-SARS-CoV-2-plasma or prednisone for COVID-19 [not all dosages and routes stated]. Patient was a former smoker (27 pack years) and had ankylosing spondylitis and ILD, treated with rituximab and prednisone, developed severe COVID-19 pneumonia, which required admission into ICU, despite being fully vaccinated with tozinameran [Pfizer-BioNTech-COVID-19 vaccine]. Seven weeks after the infusion of rituximab, he received his first of 2 vaccine doses. And 2nd dose was administered 3 weeks after the 1st dose. He was tested COVID-19 positive 7 weeks after full vaccination and presented to the hospital after 3 days of symptoms onset. Since the initiation of rituximab 4 year prior, upon flow cytometry, undetectable levels of CD19+/20+ cells were found in his blood, which remained undetectable on repeat testing during hospitalization. Therefore, he received off-label treatment with 2 10-day courses of dexamethasone, 2 doses of  Convalescent-anti-SARS-CoV-2-plasma [convalescent plasma]. He also received 2 10-day courses of remdesivir. He was placed on nasal cannula (NC) for 14 days before requiring escalation to high flow nasal cannula (HFNC) for 38 days. He showed no significant marked improvement in his respiratory status after 55 days from symptoms onset, he was died.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   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: death