Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Biopsy skin, Blood bilirubin, Blood creatinine
Clinical narrative: cutaneous hypersensitivity reaction with end-organ dysfunction; liver dysfunction; This is a literature report.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing), notes: remote history. The patient's concomitant medications were not reported. Past drug history included: Meloxicam for back pain, notes: 1 week prior to the rash onset. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization. The following information was reported: DERMATITIS ALLERGIC (hospitalization, medically significant), outcome "recovering", described as "cutaneous hypersensitivity reaction with end-organ dysfunction"; HEPATIC FUNCTION ABNORMAL (hospitalization, medically significant), outcome "recovering", described as "liver dysfunction". The patient underwent the following laboratory tests and procedures: alanine aminotransferase: 1201 IU/l, notes: Elevated  Peak value: 1852; improvement; aspartate aminotransferase: 425 IU/l, notes: elevated  peak value: 642; improvement; biopsy skin: demonstrated interface dermatitis and a perivascul, notes: and perifollicular lymphohistiocytic infiltrate without eosinophilia; blood bilirubin: 7.9 mg/dl, notes: elevated, peak value: 12.5; improvement; blood creatinine: normal; improvement; blood iron: unremarkable; ceruloplasmin: unremarkable; cytomegalovirus test: unremarkable; epstein-barr virus test: unremarkable; full blood count: normal, notes: without eosinophilia; hepatitis viral test: unremarkable; herpes simplex test: negative; herpes virus test: negative; hiv test: unremarkable; investigation: unremarkable; magnetic resonance imaging abdominal: unremarkable; polymerase chain reaction: negative; ultrasound abdomen: unremarkable. Therapeutic measures were taken as a result of dermatitis allergic, hepatic function abnormal.  Clinical course: On the day following her vaccination, she experienced subjective fever, fatigue, generalized myalgia, nausea, and headache that lasted for 4 days. On day 5 following vaccination, she noticed a pruritic cutaneous eruption on her abdomen, which generalized over the next 5 days. Diffuse erythematous morbilliform papules and plaques were noted over the neck, trunk, and proximal aspects of the extremities. In addition, there were faintly targetoid erythematous-to-violaceous plaques over the distal aspects of the extremities extending onto the palms and soles. There was no lymphadenopathy or mucosal involvement; however, the patient was jaundiced. The patient was admitted to a local hospital, and she was subsequently transferred to our institution for inpatient dermatologic care. Laboratory results on admission were notable for a normal complete blood cell count without eosinophilia, normal creatinine level, elevated alanine aminotransferase level of 1201 U/L (peak value, 1852 U/L), elevated aspartate aminotransferase level of 425 U/L (peak value, 642 U/L), and elevated total bilirubin level of 7.9 mg/dL (peak value, 12.5 mg/ dL). Herpes simplex virus, human herpesvirus 6, and Mycoplasma pneumoniae polymerase chain reaction serologies were negative. A skin biopsy demonstrated interface dermatitis and a perivascular and perifollicular lymphohistiocytic infiltrate without eosinophils Extensive workup for the cause of acute hepatitis, including viral hepatitis panel, cytomegalovirus, Epstein-Barr virus, ceruloplasmin, iron, HIV, a1- antitrypsin, ultrasound of the upper portion of the right quadrant, and magnetic resonance imaging of the abdomen, was unremarkable. The patient's acute hepatitis was ultimately attributed to a vaccine- induced hypersensitivity reaction with end-organ dysfunction. The patient denied having taken any medications or supplementation, apart from 1 dose of meloxicam 1 week prior to the rash onset for back pain and acetaminophen/ibuprofen 1 day prior to the rash onset for headache and myalgia following vaccination. A reaction to these medications could not be ruled out, however this was deemed much less likely as the patient had taken these medications intermittently in the past. Clinicopathologic correlation and the Regulatory Authority of Severe Cutaneous Adverse Reactions score of 3 supported a cutaneous hypersensitivity reaction with liver dysfunction likely triggered by the COVID-19 vaccine. The patient was treated with intravenous methyl- prednisolone and topical corticosteroids. She was transitioned to oral prednisone with improvement in her cutaneous eruption and liver function tests. It was recommended that the patient should proceed cautiously with future booster doses of the Pfizer COVID-19 vaccine.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events