Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 RNA, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: patient had persistent infection through; patient had persistent infection through; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Azathioprine, stop date: May2020, for Rheumatoid arthritis, reaction(s): "COVID-19"; Azathioprine, stop date: May2020, for Rheumatoid arthritis, reaction(s): "Pneumonia"; Rituximab, stop date: May2020, for Rheumatoid arthritis, reaction(s): "COVID-19"; Rituximab, stop date: May2020, for Rheumatoid arthritis, reaction(s): "Pneumonia". The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), all with latency 3 months after the suspect product(s) administration, outcome "recovered" (25Mar2021) and all described as "patient had persistent infection through". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: (Jan2021) seronegative; (Mar2021) seronegative; (Sep2021) Positive, notes: 512 Units-Au/ml; (Dec2021) Positive, notes: 621 Units-Au/ml; Gene sequencing: (unspecified date) unknown, notes: sequenced using targeted amplicon NGS sequencing (Next-Generation Sequencing) with backup sequencing on a nanopore platform; Viral sequencing: (unspecified date) unknown results; (unspecified date) indicated a persistent infection with a lineage, notes: B.1.585.3 virus that accumulated 14 mutations throughout the infection. Two mutations (S494P, S D737Y) are associated with therapy resistance and are similar to those found in other immunocompromised individuals with persistent COVID-19. Additional mutations were of unknown consequence; SARS-CoV-2 antibody test: (02Mar2021) Negative; (26Mar2021) Negative, notes: S Protein; (11May2021) Positive; SARS-CoV-2 RNA: (unspecified date) positive; SARS-CoV-2 test: (06Nov2020) Positive; (21Nov2020) Positive; (25Nov2020) Positive; (30Nov2020) Positive; (03Dec2020) Positive; (29Dec2020) Positive; (07Jan2021) Positive; (25Jan2021) Positive; (17Mar2021) Positive; (25Mar2021) Negative; (Jul2020) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The COVID-19 pandemic has been marked by long-term persistence of SARS-CoV-2 in immunocompromised patients receiving B-cell-depleting therapies, with many individuals experiencing fatal COVID-19. They reported an individual treated with rituximab who survived persistent COVID-19 over 9 months. SARS-CoV-2 positive RNA samples were sequenced using targeted amplicon NGS sequencing with backup sequencing on a nanopore platform. The resulting sequences were analyzed for genomic variance over time at the consensus and sub-consensus level. An individual with rheumatoid arthritis (RA) treated with azathioprine and rituximab (last dose in May 2020) was diagnosed with COVID-19 in July 2020 and admitted with pneumonia. After initial incomplete recovery, the patient had persistent infection through March 2021 and received both remdesivir and convalescent plasma (January 2021). The patient received three doses of mRNA vaccine (Pfizer BioNTech) in December 2020, April 2021, and November 2021, but was seronegative for nucleocapsid IgG in both January 2021 and March 2021; positive spike IgG developed by September 2021 (512 AU/ml) and December 2021 (621 AU/ml) (Figure 1). The patient recovered with new oxygen dependence (2-3L) and manages RA off B-cell depletion; they required an extended corticosteroid taper to manage organizing pneumonia and treatment for several opportunistic infections. Viral sequencing over the course of illness indicated a persistent infection with a lineage B.1.585.3 virus that accumulated 14 mutations throughout the infection. Two mutations (S494P, S D737Y) are associated with therapy resistance and are similar to those found in other immunocompromised individuals with persistent COVID-19. Additional mutations were of unknown consequence. SARS-CoV-2 was able to establish persistent infection and accumulated mutations associated with therapeutic resistance; repeated vaccination was associated with successful resolution following repeated vaccination after stopping rituximab. Cessation of B-cell-depleting therapy was likely the critical factor in the patient's recovery, but repeated vaccination was associated with a delayed seroconversion in this patient with reversibly immunosuppression.; Sender's Comments: Based on the available information in the case, the causal association between the events  Covid-19 and drug ineffective  and the suspect drug BNT162B2 cannot be excluded,Linked Report(s) : US-PFIZER INC-202300037715 Same article/patient/ drug and different event;