Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow, Biopsy lymph gland, Biopsy skin, COVID-19, Cutaneous sarcoidosis
Clinical narrative: erythrodermic sarcoidosis; COVID-19 infection; COVID-19 infection; This is a literature report for the following literature source(s).  An 80-year-old female patient received bnt162b2 (BNT162B2), in Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19 infection"; CUTANEOUS SARCOIDOSIS (medically significant), outcome "not recovered", described as "erythrodermic sarcoidosis". The patient underwent the following laboratory tests and procedures: Biopsy bone marrow: (unspecified date) patchy histiocytic infiltrate, notes: non-necrotizing granulomas, and extensive fibrosis; Biopsy lymph gland: (unspecified date) not diagnostic; Biopsy skin: (unspecified date) a dermal-based lymphomatoid, notes: Repeated skin biopsy, vascular reaction with supervening interstitial granulomatous features consistent with a drug-associated T-cell dyscrasia; (unspecified date) revealed interstitial, notes: Repeated biopsy including full-thickness skin and fascia, and sarcoidal-like granulomatous infiltrate; (Jun2022) showed patchy lichenoid, notes: in June 2022, perivascular dermatitis with slight epidermal spongiosis and numerous eosinophils, and the patient developed complete hair-loss by July 2022; (May2023) pre-lymphomatous erythrodermic T-cell dyscrasia; Positron emission tomogram: (unspecified date) low-grade FDG uptake, notes: in the lungs, hypermetabolic infiltration in the bone marrow, and hypermetabolic nodules involving subcutaneous aponeurosis and thoracic lymph nodes. Therapeutic measures were taken as a result of cutaneous sarcoidosis.  Clinical course: Reported as, A previously healthy 80-year-old female developed acute arthritis two weeks following Pfizer SARS-CoV-2 booster vaccination in October 2021, which temporarily improved after treatment with prednisone. In April 2022, she developed erythroderma, severe pruritus, lymphadenopathy, and significant eosinophilia.Skin biopsy in June 2022 showed patchy lichenoid and perivascular dermatitis with slight epidermal spongiosis and numerous eosinophils, and the patient developed complete hair-loss by July 2022. The patient experienced progression of all symptoms after COVID-19 infection in November 2022, and lymph node biopsy performed at that time was not diagnostic. Skin biopsy in May 2023 showed pre-lymphomatous erythrodermic T-cell dyscrasia. The patient had persistent erythroderma and pruritus despite recent treatment with dupilumab and was referred to REDACTED in June 2023 for further management of suspected Se'zary syndrome. Repeated skin biopsy demonstrated a dermal-based lymphomatoid vascular reaction with supervening interstitial granulomatous features consistent with a drug-associated Tcell dyscrasia. All non-essential drugs were discontinued, yet the patient's symptoms persisted. PET-CT showed low-grade FDG uptake in the lungs, hypermetabolic infiltration in the bone marrow, and hypermetabolic nodules involving subcutaneous aponeurosis and thoracic lymph nodes. Repeated biopsy including full-thickness skin and fascia revealed interstitial and sarcoidal-like granulomatous infiltrate. Bone marrow biopsy showed patchy histiocytic infiltrate, non-necrotizing granulomas, and extensive fibrosis. Taken together, diagnosis of erythrodermic sarcoidosis with systemic involvement, potentially associated with the COVID-19 vaccine, was made. JAK inhibitors have recently shown promising results in sarcoidosis, so the patient was started on tofacitinib and response is ongoing. Sarcoidosis is a multisystem inflammatory condition of unknown etiology, characterized by granuloma formation and immune dysregulation amid antigenic exposure. This case provides insight into the etiopathology of granulomatous inflammation in sarcoidosis. The progression of symptoms following the COVID-19 vaccines and subsequent COVID infection is suggestive of antigenic stimulation inciting molecular mimicry, resulting in sarcoidosis.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely 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.