Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Cutaneous vasculitis, Discomfort, Drug hypersensitivity, Hypogammaglobulinaemia
Clinical narrative: salivary gland removal; leukocytoclastic vasculitis; Mild hypogammaglobulinemia; allergic to it; Parotiditis; major discomfort; Perivascular lymphocytic dermatitis with purpura; Perivascular lymphocytic dermatitis with purpura; rash; increased sjogren's; increased sjogren's; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6202) at the age of 78 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CREST Scleroderma", start date: 1993 (ongoing); "Hashimoto's Thyroiditis" (unspecified if ongoing); "Thyroidectomy", start date: 2003 (unspecified if ongoing); "Colectomy-bladder-Fistula", start date: 2003 (unspecified if ongoing); "bladder-Fistula", start date: 2003 (unspecified if ongoing); "sulfa allergies" (unspecified if ongoing), notes: sulfa allergies; "iodine allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: SJOGREN'S SYNDROME (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 27Feb2021, outcome "unknown" and all described as "increased sjogren's"; RASH (non-serious) with onset 19Mar2021, outcome "unknown"; SALIVARY GLAND RESECTION (medically significant), outcome "unknown", described as "salivary gland removal"; CUTANEOUS VASCULITIS (medically significant), outcome "unknown", described as "leukocytoclastic vasculitis"; HYPOGAMMAGLOBULINAEMIA (medically significant), outcome "unknown", described as "Mild hypogammaglobulinemia"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic to it"; PAROTITIS (non-serious), outcome "unknown", described as "Parotiditis"; DISCOMFORT (non-serious), outcome "unknown", described as "major discomfort "; SUPERFICIAL INFLAMMATORY DERMATOSIS (non-serious), PURPURA (non-serious), outcome "unknown" and all described as "Perivascular lymphocytic dermatitis with purpura". The events "increased sjogren's" and "rash" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (05May2022) extravasated erythrocytes and superficial perivasc. Therapeutic measures were taken as a result of sjogren's syndrome, condition aggravated, superficial inflammatory dermatosis, purpura. Therapeutic measures were not taken as a result of rash.   Clinical course: After each dose, sjogren's worsened to the point of significant loss of body fluid in all gland areas, Pa-rotiditis, salivary gland removal and major discomfort occurred. The rash appeared after initial dose and increased after each dose. Doctors kept telling it was telangtasis but patient knew it was something else. Rheumatologist referred her to medical dermatologist where biopsy was done. Treated with rutin, high vitamin C and cream, continued to worsen and finished methoprednisone pack 6 wks ago, that helped but leg scarring is not going away. In addition, had essential tremors after 3 dose. Neurologist, dermatologist and immunologist all agree it is due to the vaccine.Final Diagnosis: Skin, left proximal pretibial region: Perivascular lymphocytic dermatitis with purpura. Comment: Similar morphological changes can be seen within the spectrum of findings present in pigmented pur-puric dermatosis, which is favored in this biopsy. While an evolving lesion of leukocytoclastic vasculitis cannot be entirely excluded, diagnostic features are not observed in multiple level sections examined. Microscopic Description: (Images represent only selected aspects of the pathologic examination and should not be considered diagnostic by themselves.) The stain quality is adequate. Histologic sections are of skin. There are extravasated erythrocytes and superficial perivascular lymphocytic infiltrate. Level sections are examined. Neutrophilic infiltrate or leukocytoclastic debris is not identified. The epidermis is intact with patchy spongiosis and basket-woven orthokeratosis. Gross Description Submitted in formalin; Designated: "Right proximal pretibial region", Inventory: Skin punch: Dimensions: 0.3 cm diameter, 0.3 cm in depth: Cutaneous surface: Tan, mottled; The specimen is inked orange and submitted entirely as (A1). Clinical History Morphology: Palpable purpura with necrotic centers; DDX: Vasculitis.Interpretation, Spep: Mild hypogammaglobulinemia. No monoclonal protein seen. The differential diagnosis includes hu-moral immunodeficiency (congenital, idiopathic, disease-related. Therapy-related/teratogenic etc.), light chain disease, low level monoclonal protein or amyloidosis. If undiagnosed, further evaluation can include serum free light chain analysis, urine immunoelectrophoresis or serum immunoelectrophoresis. This result does not meet criteria for reflex testing, but serum immunoelectrophoresis can be added on this specimen (call laboratory to add appropriate testing as clinically indicated); Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300016867 same patient, different dose/event;US-PFIZER INC-202300150236 same patient, different dose/event;