Sex: F
Vaccine: COVID19
Symptoms: B-lymphocyte count abnormal, Glomerular filtration rate, Intentional product misuse, Off label use, Protein urine
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; INTENTIONAL PRODUCT MISUSE; OFF LABEL USE; This spontaneous report was received from literature.   This report concerned a 70 year old female of unspecified ethnicity. Initial information was processed along with additional information on 21-SEP-2021. The objective of this study was to describe the impact of rituximab on humoral response to COVID-19 booster vaccine and antibody kinetics in patients with ANCA vasculitis. The patient's height, and weight were not reported. The patient's concurrent conditions included: ANCA (anti-neutrophil cytoplasmic antibody) type MPO (myeloperoxidase) associated vasculitis, and microscopic polyangiitis. The patient had no previous COVID-19 infection. The patient was previously treated with rituximab for microscopic polyangiitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Patient did not required dialysis during periods of vaccination. Concomitant medications included unspecified steroids and cyclophosphamide for induction of immunosuppression. The patient was initially received 2 doses of the Pfizer vaccine (BNT162) for prophylactic vaccination and had not mount a humoral response for prophylactic vaccination.  On an unspecified date, the patient experienced suspected immunological vaccination failure, intentional product misuse and off label use. Laboratory data (dates unspecified) included: CD19 lymphocyte count abnormal (NR: not provided) less than 20 (0) cell/mL (percent), Estimated GFR (NR: not provided) 44 mL/min/{1.73_m2}, Protein urine (NR: not provided) 219 mg, and SARS-CoV-2 IgG antibody test (NR: not provided) less than 1. Immunoglobulin G antibodies to spike protein S1 subunit of on SARS-CoV-2 were measured using ELISA (Enzyme-linked immunosorbent assay) at least one month post completion of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccination failure, intentional product misuse and off label use was not reported. The author has provided data for the first demonstration of antibody development post booster dose of the COVID-19 vaccine in associated vasculitis (AAV) patients on rituximab maintenance therapy. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20210927182 and 20210935336. This report was associated with a product quality complaint: 90000194198.; Sender's Comments: V0-20210935307-covid-19 vaccine ad26.cov2.s -Suspected Immunological vaccine failure. This event(s) is considered not related. 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