Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Body surface area, SARS-CoV-2 test, Toxic epidermal necrolysis
Clinical narrative: Toxic Epidermal Necrolysis after COVID-19 mRNA-1237 Vaccination; This literature-non-study case was reported in a literature article and describes the occurrence of TOXIC EPIDERMAL NECROLYSIS (Toxic Epidermal Necrolysis after COVID-19 mRNA-1237 Vaccination) in a 30-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   The patient's past medical history included Respiratory distress and Gastrointestinal upset. Concurrent medical conditions included Exercise induced asthma, Polycystic ovarian syndrome, Obesity, Migraine, Hypermobility syndrome, Irritable bowel syndrome, Depression, Anxiety, Attention deficit hyperactivity disorder, Drug allergy, Drug allergy, Drug allergy and Rash. Concomitant products included DEXAMETHASONE for Sores mouth, IBUPROFEN, MODAFINIL, ARIPIPRAZOLE, BUSPIRONE, CHOLECALCIFEROL, CITALOPRAM, CYANOCOBALAMIN, FERROUS SULFATE, LINACLOTIDE, ETHINYLESTRADIOL, NORGESTIMATE (MONO LINYAH), TRIAMCINOLONE, CHLORHEXIDINE and HYDROXYZINE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOXIC EPIDERMAL NECROLYSIS (Toxic Epidermal Necrolysis after COVID-19 mRNA-1237 Vaccination) (seriousness criteria hospitalization and medically significant). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency; CETIRIZINE ongoing since an unknown date at a dose of 10 milligram twice a day; METHYLPREDNISOLONE at a dose of 125 microgram every six hours; ALLANTOIN, HEPARIN SODIUM (FLEBOGAMMA [ALLANTOIN;HEPARIN SODIUM]) (intravenous use) at a dose of 5 % percent and BENZALKONIUM CHLORIDE at an unspecified dose and frequency. At the time of the report, TOXIC EPIDERMAL NECROLYSIS (Toxic Epidermal Necrolysis after COVID-19 mRNA-1237 Vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: showed interface dermatitis with dyskeratotic epidermis, intact stratum corneum, and focal re-epithelialization consistent with  erythema multiforme (EM).. On an unknown date, Body surface area: coverage was estimated at 30%40%. On an unknown date, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered TOXIC EPIDERMAL NECROLYSIS (Toxic Epidermal Necrolysis after COVID-19 mRNA-1237 Vaccination) to be related.    The patient and her husband both received the mRNA-1273 vaccine on the same day. That night, she noticed swelling in her fingers that prompted her to take ibuprofen, which she had taken as needed prior to that day. Two days later, she noticed a cluster of skin lesions around the injection site on her left arm. By Day 12 after injection, her rash continued to spread and she was seen at an outside clinic. Presumed diagnosis at the clinic was erythema multiforme (EM) versus StevensJohnson syndrome (SJS) due to classic targetoid lesion appearance of her rash. That same day, she was sent to the emergency department again for admission. On admission, her rash was described as confluent diffuse erythematous targetoid rash on the face and chest with bullae present in the axillae and back. She was also noted to have some skin sloughing on the back, scattered lesions on her abdomen and legs, and desquamating oral lesions with crusting around her eyes and injection of the conjunctive. After she failed to improve, she was given IV flebogamma 5%. The patient reported the use of benzalkonium chloride spray on her back at some time during her admission that led to worsening of the skin on her back with more blistering and sloughing. As she continued to worsen, our hospital was contacted for admission to the burn unit for care.  Transfer occurred on Day 16 after vaccination. Over the course of her admission to hospital, total body surface area (TBSA) coverage was estimated at 30%40%, suggesting progression to toxic epidermal necrolysis (TEN). Psychiatry was also consulted for management of the patient's psychiatric medications. Psychiatry restarted her on buspirone and citalopram. The patient was discharged home on Day 21. Patient reported a colonoscopy with prep (polyethylene glycol (PEG) 3350) that occurred after her TEN reaction without incident.  Company comment:  This is a literature non-study case concerning a 30-year-old female patient, with medical history of Depression, Anxiety, Attention deficit hyperactivity disorder, allergy to topiramate, cephalosporins and benzalkonium chloride reported, who experienced unexpected serious (medically significant, hospitalization) AESI of Toxic epidermal necrolysis(TEN) in context of vaccination with dose of mRNA-1273 which was unknown dose in Covid-19 vaccination schedule. Latency cannot be calculated due to exact vaccination and event onset dates unknown. It is of importance to note that concomitant medications included MODAFINIL started 3 months before event onset and ARIPIPRAZOLE started 7 months before event onset. The course of events started on the night after vaccination with swelling in fingers for which the patient has taken ibuprofen. Two days later a cluster of skin lesions around the injection site on the left arm was noticed and primary care provider prescribed prednisone, cetirizine, and hydroxyzine. By Day 12 after injection, the rash continued to spread and the patient was consulted in ambulatory mode. Presumed diagnosis at the clinic was erythema multiforme (EM) versus StevensJohnson syndrome (SJS) due to classic targetoid lesion appearance of the rash. Diagnostic work up included biopsy which showed interface dermatitis with dyskeratotic epidermis, intact stratum corneum, and focal re-epithelialization consistent with erythema multiforme (EM). That same day, the patient was sent to the emergency department and was admitted to hospital. On admission, the rash was described as confluent diffuse erythematous targetoid rash on the face and chest with bullae present in the axillae and back. Some skin sloughing on the back, scattered lesions on the abdomen and legs, and desquamating oral lesions with crusting around eyes and injection of the conjunctive were observed. Treatment with methyloprednisolone 125 mcg every 6 hours was started and planned for 5 days. After no improvement, the patient was given IV flebogamma 5%. The patient reported the use of benzalkonium chloride spray on the back at some time during the admission that led to worsening of the skin on the back with more blistering and sloughing. As it continued to worsen, burn unit was contacted for admission. The patient was transferred on 16 day after vaccination and at that time total body surface area (TBSA) coverage was estimated at 30%40%, suggesting progression to toxic epidermal necrolysis (TEN). Dermatology recommended hydroxyzine 25 mg nightly, cetirizine 10 mg twice daily, and a dexamethasone 0.1 mg/mL rinse for mouth lesions with an antiseptic diluted chlorohexidine rinse. Psychiatry department was also consulted for management of the patient's psychiatric medications; modafinil and aripiprazole were stopped on suspicion of causing TEN and the patient was restarted on buspirone and citalopram. Hospital discharge took place on Day 21 after vaccination. Medical history of allergy to topiramate, cephalosporins and benzalkonium chloride can be considered as confounders. Concurrent use of modafinil and aripiprazole with ibuprofen use as needed can be considered as contributors to the event development as all of these have been reported to be associated with TEN. Authors considered that as these medications were started at least 10 weeks before vaccination or were taken previously, suspicion of them contributing to the event is low. Based on temporal relationship and the reaction starting around the injection site, the vaccine was assessed as initiator of reaction and hence causality cannot be excluded. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.