Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, COVID-19, Drug eruption, Pathology test
Clinical narrative: diffuse cutaneous drug eruption; This literature-non-study case was reported in a literature article and describes the occurrence of DRUG ERUPTION (diffuse cutaneous drug eruption) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.       Concurrent medical conditions included Anxiety disorder. Concomitant products included ALPRAZOLAM and SERTRALINE for Anxiety disorder.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced DRUG ERUPTION (diffuse cutaneous drug eruption) (seriousness criterion medically significant). The patient was treated with HYDROCORTISONE (topical) at an unspecified dose and frequency; METHYLPREDNISOLONE at an unspecified dose and frequency; TRIAMCINOLONE ACETONIDE (topical) at a dose of UNK UNK, bid; CETIRIZINE (oral) at a dose of 10 milligram twice a day and HYDROXYZINE (oral) for Symptomatic treatment, at a dose of 10 milligram. At the time of the report, DRUG ERUPTION (diffuse cutaneous drug eruption) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: demonstrated a moderately dense inflammatory infiltrate within the dermis, primarily in a perivascular distribution. The infiltrate consisted mainly of lymphocytes and eosinophils with occasional histiocytes consistent with drug hypersensitivity. The histopathologic differential diagnosis included papular urticaria or drug eruption . Site was a plaque on her left anterior proximal thigh. On an unknown date, COVID-19: (Negative) was tested for COVID-19 several times throughout the past year and received negative results most recently the day prior to the dermatology office visit.. On an unknown date, Pathology test: consistent with drug eruption.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient presented to the dermatology office on 18-Jan-2021 for a severely pruritic and diffusely painful rash which had been worsening over the past 12 days. It was reported that hours after vaccination, patient was felt soreness and experienced an erythematous patch on the inner portion of her left arm, medial to the injection site. After next few days, the eruption spread more diffusely on patient body and persisted.  On 11-JAN-2021, patient was went to primary care physician who gave her an intramuscular corticosteroid injection, patient had no change in her symptoms so a second intramuscular corticosteroid injection was given on 17-JAN-2021. Patient denied any systemic symptoms, such as fevers, chills, cough, diarrhea, taste or smell. On presentation, patient exhibited pruritic erythematous papules, coalescing into plaques, symmetrically involving the upper and lower extremities and trunk bilaterally.  A diagnosis of drug reaction was suspected and punch biopsy was performed.  Treatment drug hydroxyzine was prescribed at night as needed for symptomatic relief.  Patient was scheduled for follow up in 2 weeks for suture removal and re-evaluation. Upon follow up, cutaneous eruption has cleared and patient denied any further symptoms or adverse reactions to the vaccine. Patient was advised not to take the second vaccine injection and is in communication with the Centers for Disease Control to discuss alternative vaccination methods. It was stated that the patient did not receive a total IgE or blood eosinophil count which may have also facilitated finding the etiology of this cutaneous eruption.  It was reported when a dermatologist encounters a patient with clinical and pathological findings consistent with drug eruption.  Company Comment: This literature non-study case concerns a 40-year-old female patient, with medical history of anxiety disorder on oral alprazolam and sertraline, with no recent medication changes or dosage adjustments reported, experienced the unexpected serious (medically significant) event of Drug eruption (reported as diffuse cutaneous drug eruption) on the same day after first dose of mRNA-1273 vaccination. Hours after vaccination, patient felt soreness and had an erythematous patch on the inner portion of her left arm, medial to the injection site. Over the next few days, the eruption spread more diffusely on her body and persisted. Patient consulted primary care physician five days after vaccination, and was treated with an intramuscular corticosteroid injection, was prescribed topical hydrocortisone along with a methylprednisolone dose pack for symptomatic relief. As her symptoms persisted, second intramuscular corticosteroid injection was given a week later. She consulted dermatologist the next day as the severely pruritic, diffusely painful rash was worsening over the past 12 days. COVID-19 test done several times prior to vaccination and after also showed negative results. She denied any systemic symptoms, such as fevers, chills, cough, diarrhea, taste or smell. On presentation, she exhibited pruritic erythematous papules, coalescing into plaques, symmetrically involving the upper and lower extremities and trunk bilaterally. A diagnosis of drug reaction was suspected and punch biopsy was performed. Patient was prescribed triamcinolone acetonide 0.1% cream to apply twice daily for two weeks, cetirizine 10 mg orally twice daily, and hydroxyzine 10 mg orally at night as needed for symptomatic relief. Histopathology of the biopsy sample demonstrated a moderately dense inflammatory infiltrate within the dermis, primarily in a perivascular distribution. The infiltrate consisted mainly of lymphocytes and eosinophils with occasional histiocytes, consistent with that of drug eruption. Upon follow up after 2 weeks, her cutaneous eruption was cleared, and she denied any further symptoms or adverse reactions to the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2022: Follow up received by safety on 19-Dec-2022 has email with full text article received and contains significant information: Reporter information, literature information was updated, lab data and medical history was added. drug information was added, event information were updated; Sender's Comments: This literature non-study case concerns a 40-year-old female patient, with medical history of anxiety disorder on oral alprazolam and sertraline, with no recent medication changes or dosage adjustments reported, experienced the unexpected serious (medically significant) event of Drug eruption (reported as diffuse cutaneous drug eruption) on the same day after first dose of mRNA-1273 vaccination. Hours after vaccination, patient felt soreness and had an erythematous patch on the inner portion of her left arm, medial to the injection site. Over the next few days, the eruption spread more diffusely on her body and persisted. Patient consulted primary care physician five days after vaccination, and was treated with an intramuscular corticosteroid injection, was prescribed topical hydrocortisone along with a methylprednisolone dose pack for symptomatic relief. As her symptoms persisted, second intramuscular corticosteroid injection was given a week later. She consulted dermatologist the next day as the severely pruritic, diffusely painful rash was worsening over the past 12 days. COVID-19 test done several times prior to vaccination and after also showed negative results. She denied any systemic symptoms, such as fevers, chills, cough, diarrhea, taste or smell. On presentation, she exhibited pruritic erythematous papules, coalescing into plaques, symmetrically involving the upper and lower extremities and trunk bilaterally. A diagnosis of drug reaction was suspected and punch biopsy was performed. Patient was prescribed triamcinolone acetonide 0.1% cream to apply twice daily for two weeks, cetirizine 10 mg orally twice daily, and hydroxyzine 10 mg orally at night as needed for symptomatic relief. Histopathology of the biopsy sample demonstrated a moderately dense inflammatory infiltrate within the dermis, primarily in a perivascular distribution. The infiltrate consisted mainly of lymphocytes and eosinophils with occasional histiocytes, consistent with that of drug eruption. Upon follow up after 2 weeks, her cutaneous eruption was cleared, and she denied any further symptoms or adverse reactions to the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.