Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Epidermal necrosis, Immunohistochemistry, Investigation, Lichenoid keratosis
Clinical narrative: Epidermal necrosis with lichenoid reaction; Epidermal necrosis with lichenoid reaction; she presented with a mild pruritic rash on both forearms; Widespread cutaneous eruption; This is a literature report for the following literature source(s).  A 74-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Non-small cell lung cancer stage III", start date: 2015 (ongoing); "lobectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pemetrexed for Non-small cell lung cancer stage III, reaction(s): "disease recurrence", notes: 3 years after initial diagnosis.; Cisplatin for Non-small cell lung cancer stage III, reaction(s): "disease recurrence", notes: 3 years after initial diagnosis.; Durvalumab, start date: 2018, for Non-small cell lung cancer stage III, reaction(s): "disease progression"; Pembrolizumab, start date: 2020, for Non-small cell lung cancer stage III, notes: fixed dose 200mg, leading to maintenance of stable disease; Pemetrexed, start date: 2020, for Non-small cell lung cancer stage III, notes: 755 mg every 21 days, leading to maintenance of stable disease. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 immunization, reaction(s): "no cutaneous or other adverse reactions"; Bnt162b2 (DOSE 2, SINGLE), administration date: Mar2021, for COVID-19 immunization, reaction(s): "no cutaneous or other adverse reactions". The following information was reported: EPIDERMAL NECROSIS (medically significant), LICHENOID KERATOSIS (medically significant), outcome "recovering" and all described as "Epidermal necrosis with lichenoid reaction"; RASH PRURITIC (medically significant), 3 days after the suspect product(s) administration, outcome "recovered", described as "she presented with a mild pruritic rash on both forearms"; RASH (medically significant), 3 days after the suspect product(s) administration, outcome "recovered", described as "Widespread cutaneous eruption". The patient underwent the following laboratory tests and procedures: Biopsy skin: Epidermal necrosis with lichenoid reaction.; Immunohistochemistry: revealing a positivity rate of 2%., notes: of programmed cell death-1 ligand expression was performed using a commercially available kit; Examination: numerous 2-5mm pink-purple papules on both forearm, notes: the dorsal aspects of the hands, chest, legs, buttock, and lower back without any mucosal or palmoplantar involvement; egs, many with overlying hemorrhagic crust. Therapeutic measures were taken as a result of epidermal necrosis, lichenoid keratosis, rash pruritic, rash.  Clinical course: Three days after receiving the COVID-19 booster dose the patient presented with a mild pruritic rash on both forearms. Seven days after booster dose administration, the patient received her cycle 13 infusion of pembrolizumab/pemetrexed, leading to acute worsening and spreading of the cutaneous eruption. The patient had not developed any cutaneous reactions to the pembrolizumab regimen. The patient unsuccessfully trialed hydrocortisone 1% cream before seeing oncodermatology and was started on triamcinolone 0.1% cream applied to affected areas twice daily for 2 weeks. She noted mild improvement in those areas to which steroid cream was applied, but over the following 3 weeks, she noticed a pattern of mild resolution of old lesions alongside eruption of newly pruritic pink papules. Lesion development was characterized by a deep-red darkening of color with cessation of pruritus and sensation of warmth but with increased abundance of hemorrhagic crust at outer edges of lesions. Due to the lack of resolution, triamcinolone cream was discontinued, and the more potent clobetasol 0.05% cream was initiated for twice-daily application. After 2 weeks of clobetasol cream treatment, significant improvement was noted. The rash improved significantly on the upper arms, forearms, dorsal aspects of the thighs, posterior aspects of the thighs, lower legs, and dorsal aspects of the feet and was particularly more confluent and much flatter with more violaceous hyperpigmentation noted.; Sender's Comments: Based on the temporal relation, the association between the events of epidermal necrosis, lichenoid keratosis, rash pruritic and rash and the suspect product BNT162B2 cannot be completely ruled out. 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.