Sex: M
Vaccine: COVID19
Symptoms: Vasculitis necrotising
Clinical narrative: This is a literature report for the following literature source(s): "Nicolau Syndrome After Glatiramer Acetate Injection in Close Proximity to Administration of SARS-CoV-2 mRNA Vaccine", Neurology neuroimmunology & neuroinflammation. A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; glatiramer acetate (GLATOPA) (Batch/Lot number: unknown) for 5 years as 40 mg, 3x/day for multiple sclerosis. Relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "obesity" (unspecified if ongoing), notes: body mass index of 30.1 kg/m^2; "multiple sclerosis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: Mar2021, for COVID-19 immunization. The following information was reported: EMBOLIA CUTIS MEDICAMENTOSA (medically significant) with onset 2021, outcome "recovered" (2021), described as "Nicolau Syndrome"; DRUG INTERACTION (medically significant) with onset 2021, outcome "recovered" (2021), described as "Occurrence of Nicolau syndrome in 2 patients with MS at our MS center in close proximity to SARS-CoV2 vaccination with mRNA vaccines raises the possibility of an association between the 2". The patient underwent the following laboratory tests and procedures: biopsy: contained fibrin thrombi in the superficial and, notes: deep dermis, along with tissue necrosis indicative of thrombotic vasculopathy (Figure, D); body mass index: 30.1, notes: kg/m^2; magnetic resonance imaging: without new mri lesions or relapses. The action taken for glatiramer acetate was unknown. Therapeutic measures were taken as a result of embolia cutis medicamentosa. Clinical course: A 62-year-old man with a history of hyperlipidemia, obesity (body mass index of 30.1 kg/m2), and MS received the first dose of the BNT162b2 vaccine in late March 2021.2 The patient had been stable on GA 40 mg three times a week (Glatopa) for the past 5 years without new MRI lesions or relapses and no serious injection reactions. An injection of GA given in the lateral abdomen 17 days after the first vaccine dose resulted in retiform purpura surrounding the injection site (Figure, A). The purpura appeared 1 day before the second dose of the BNT162b2 vaccine and subsequently continued to spread (Figure, B). The injection site developed a necrotic black eschar (Figure, C). A punch biopsy obtained 14 days after vaccine dose 2 contained fibrin thrombi in the superficial and deep dermis, along with tissue necrosis indicative of thrombotic vasculopathy (Figure, D). Continued administration of GA after appearance of purpura did not lead to any further injection site reactions. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events  Drug interaction with Glatiramer Acetate Injection in causing the event of "Nicolau Syndrome"  cannot be totally 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.