Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Basophil count, Biopsy, Body temperature, C-reactive protein, Chest X-ray
Clinical narrative: Drug-induced Stevens-Johnson syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of STEVENS-JOHNSON SYNDROME (Drug-induced Stevens-Johnson syndrome) in a 46-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.       Concurrent medical conditions included Type II diabetes mellitus, Hyperlipidemia and Obesity. Concomitant products included METFORMIN for Type II diabetes mellitus, ATORVASTATIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced STEVENS-JOHNSON SYNDROME (Drug-induced Stevens-Johnson syndrome) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 6 days due to STEVENS-JOHNSON SYNDROME. The patient was treated with CETIRIZINE for Adverse event, at a dose of 10 milligram once a day; PREDNISONE for Adverse event, at a dose of 60 milligram once a day; PREDNISONE for Adverse event, at a dose of 80 milligram once a day and CLOBETASOL PROPIONATE (CLOBETASOL 0.05%) ongoing since an unknown date for Adverse event, at a dose of .05 % percent twice a day. At the time of the report, STEVENS-JOHNSON SYNDROME (Drug-induced Stevens-Johnson syndrome) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Basophil count: 0.020 k/cmm (normal) 0.020 k/cmm. On an unknown date, Biopsy: confluent and full-thickness necrosis confluent and full-thickness necrosis of the epidermis with a basket weave-type stratum corneum, sparse mild perivascular infiltrate of lymphocytes in the dermis, consistent with SJS/TEN. On an unknown date, Body temperature: afebrile (normal) On arrival, patient was afebrile.. On an unknown date, C-reactive protein (Unknown-5.0): 91.38 (High) 91.38(elevated). On an unknown date, Chest X-ray: normal without infiltrates. (normal) Normal without infiltrates. On an unknown date, Eosinophil count: 0.01 k/cmm (normal) 0.01 k/cmm. On an unknown date, Full blood count: within the reference range (normal) within the reference range. On an unknown date, HIV test: negative (Negative) Negative. On an unknown date, Hepatitis B virus test: negative (Negative) Negative. On an unknown date, Hepatitis C virus test: negative (Negative) Negative. On an unknown date, Herpes simplex test: negative with detectable igg antibody titers (Negative) Negative with detectable IgG antibody titers, negative (Negative) Negative and negative (Negative) Negative. On an unknown date, Lymphocyte count (0.90-2.9): 1.7 k/cmm (normal) 1.7 k/cmm. On an unknown date, Metabolic function test: within the reference range (normal) within the reference range. On an unknown date, Mycobacterium tuberculosis complex test: negative (Negative) Negative. On an unknown date, Mycoplasma test: negative for igm  and positive  for igg antibody negative for IgM antibody and positive IgG antibody suggesting prior exposure. On an unknown date, Neutrophil count (1.70-7.0): 5.5 k/cmm (normal) 5.5 k/cmm. On an unknown date, Pathology test: revealed overlying confluent and full-thickness ne Histopathologic examination of right forearm skin biopsy showed separation of the epidermis and dermis with mild chronic inflammation composed predominately of lymphocytes (hematoxylin and eosin stain x20). Revealed overlying confluent and full-thickness necrosis of epidermis associated with mild perivascular infiltrate of lymphocytes and a basket weave-type stratum corneum. On an unknown date, Physical examination: small, dusky, purple papules Clinical photograph of patient's face showed dusky, pink-purple plaques on her eyelids and cheeks with nasal and oral mucosal sloughing. Clinical photograph of patient's face revealed nasal and oral mucosal sloughing. Clinical photograph of patient's trunk showed small, dusky, purple papules coalescing into plaques.Clinical photograph of patient arms showed small, dusky, purple papules coalescing into plaques across arms. Clinical photographs of palms showing violaceous annular lesions. Clinical photographs of soles showing violaceous annular lesions.. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Varicella virus test: negative (Negative) Negative. On an unknown date, Vital signs measurement: stable Stable. On an unknown date, White blood cell count (4.00-10.00): 7.9 k/cmm (normal) 7.9 k/cmm.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered STEVENS-JOHNSON SYNDROME (Drug-induced Stevens-Johnson syndrome) to be related.     Patient was symptomatic the day of vaccination but the following day developed oral discomfort and mucosal sloughing and was presented outside hospital 3 days after vaccination with erosions of the mucous membranes. There was no obvious vaginal sloughing, but she had not reported vaginal discomfort. She had denied any other recent illnesses, fever, chills, congestion, sore throat, or cough. She had no history of HSV infection or cold sores. Patient had denied any changes to chronic medications and was on the same regimen for several years and reported no other supplemental/as-needed medications, vitamins, nutritional supplements, or NSAID use in the preceding month. Patient was discharged to home on a prednisone taper.  Company Comment: This literature non-study case concerns a 46-year-old female patient, with no relevant medical history, who experienced the serious (hospitalization and medically significant), unexpected adverse event of significant interest Stevens-Johnson Syndrome. The patient had oral discomfort and mucosal sloughing the day after receiving the dose of mRNA 1273 COVID-19 vaccine. She presented to a hospital 3 days after the vaccine with erosions of the mucous membranes. She was given cetirizine and prednisone and was transferred to a different hospital. Upon arrival to the second hospital, patient was afebrile and vitals were stable. Physical examination revealed dusky, pink-purple plaques on her eyelids and cheeks; nasal and oral mucosal sloughing, small purple papules coalescing into plaques across her trunk and arms; and vioulaceous annular lesions on her palms and soles, with some vaginal discomfort. Patient had extensive laboratory work up, of note was the biopsy of the right forearm which was consistent with SJS. Her prednisone dosage was increased and given Clobetasol ointment. She was discharged after 6 days. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This literature non-study case concerns a 46-year-old female patient, with no relevant medical history, who experienced the serious (hospitalization and medically significant), unexpected adverse event of significant interest Stevens-Johnson Syndrome. The patient had oral discomfort and mucosal sloughing the day after receiving the dose of mRNA 1273 COVID-19 vaccine. She presented to a hospital 3 days after the vaccine with erosions of the mucous membranes. She was given cetirizine and prednisone and was transferred to a different hospital. Upon arrival to the second hospital, patient was afebrile and vitals were stable. Physical examination revealed dusky, pink-purple plaques on her eyelids and cheeks; nasal and oral mucosal sloughing, small purple papules coalescing into plaques across her trunk and arms; and vioulaceous annular lesions on her palms and soles, with some vaginal discomfort. Patient had extensive laboratory work up, of note was the biopsy of the right forearm which was consistent with SJS. Her prednisone dosage was increased and given Clobetasol ointment. She was discharged after 6 days. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.