Received Jul 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
sleep and quality of life were severely affected; sleep and quality of life were severely affected; eruptive pruritic papular porokeratosis; This literature-non-study case was reported in a literature article and describes the occurrence of POROKERATOSIS (eruptive pruritic papular porokeratosis) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Concurrent medical conditions included Eczematous dermatitis. Concomitant products included Dupilumab for Eczematous dermatitis. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced POROKERATOSIS (eruptive pruritic papular porokeratosis) (seriousness criterion medically significant). On an unknown date, the patient experienced SLEEP DISORDER (sleep and quality of life were severely affected) and QUALITY OF LIFE DECREASED (sleep and quality of life were severely affected). At the time of the report, POROKERATOSIS (eruptive pruritic papular porokeratosis) was resolving and SLEEP DISORDER (sleep and quality of life were severely affected) and QUALITY OF LIFE DECREASED (sleep and quality of life were severely affected) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2024, Biopsy skin: Two biopsies obtained from the right back and right arm demonstrated cornoid lamellae, consistent with porokeratosis. Both specimens also showed a superficial perivascular and focally lichenoid lymphohistiocytic inflammatory infiltrate a finding most often found in eruptive papular pruritic porokeratosis. Histologic features of porokeratosis showed characteristic cornoid lamella, composed of a thin column of parakeratosis overlying focal loss of the granular layer and dyskeratotic keratinocytes. The adjacent epidermis showed mild acanthosis. A superficial perivascular and interface lymphocytic inflammatory infiltrate was noted in the underlying dermis, most prominent beneath the cornoid lamella. In 2024, Fluorescent in situ hybridisation: RNA in situ hybridization (RISH) revealed expression of interferon-gamma and interleukin 13, while psoriasis-associated biomarkers interleukin 17 A and nitric oxide synthase 2 were absent. The diagnosis supported a diagnosis of eruptive pruritic papular porokeratosis. In 2024, Physical examination: Torso, back, and right distal lower extremity after 4 weeks of upadacitinib treatment, demonstrating a significant reduction in both erythema and lesion thickness. In September 2024, Physical examination: Torso, back, and right distal lower extremity prior to treatment with upadacitinib, showing multiple papules and plaques of porokeratosis with pronounced erythema. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered POROKERATOSIS (eruptive pruritic papular porokeratosis) to be related. No further causality assessments were provided for SLEEP DISORDER (sleep and quality of life were severely affected) and QUALITY OF LIFE DECREASED (sleep and quality of life were severely affected). Patient presented in September 2024 with erythematous annular and round plaques, most with peripheral and central clearing on his scalp, chest, back, and extremities. There were isolated plaques with confluent scale, and he reported that these lesions became evident in early March 2021, shortly after receiving 2 doses of the Moderna COVID vaccination and attributed their onset to a cutaneous reaction caused by the vaccine. The lesions were intensely pruritic, and excoriation resulted in widespread hemorrhagic crusting. His sleep and quality of life were severely affected. He had a personal, but not a family, history of eczematous dermatitis. For several months, compounded topical cholesterol-lovastatin ointment was applied from the knees to the ankles and weekly subcutaneous dupilumab injections were administered without benefit. Given the lack of response to dupilumab and the presence of interferon-gamma expression, the patient was transitioned to upadacitinib, a JAK1 inhibitor, at a dose of 15 mg daily, and dupilumab was discontinued. After 1 month of treatment, the patient reported marked improvement in pruritus, along with a reduction in erythema and thickness of the inflammatory component of the lesions. He continued upadacitinib 15 mg daily and resumed twice-daily application of topical cholesterol- lovastatin to the lower extremities. The clinical presentation in this case was most consistent with eruptive pruritic papular porokeratosis. Hallmark features supporting this diagnosis include the sudden development of widespread, papular lesions, severe pruritus, and histopathologic evidence of inflammation within porokeratotic lesions. In this case, the temporal association between symptom onset and COVID-19 vaccination might represent an immune- activating trigger in a predisposed host; however, this association should not be interpreted as evidence of causality. The patient's therapeutic response further supports an inflammatory-driven phenotype. Despite evidence of interleukin 13 expression, treatment with dupilumab was ineffective, suggesting that T helper type 2 signaling alone may not be the dominant driver of inflammation in this condition. In contrast, treatment with the JAK1 inhibitor upadacitinib resulted in marked improvement in pruritus and erythema, with reduction of eczematous inflammation. Author stated collectively that these findings suggest that JAK1 inhibition might represent a targeted therapeutic option for symptomatic inflammatory manifestations of eruptive pruritic papular porokeratosis, while emphasizing that such therapy should not be considered disease-modifying for porokeratosis itself.; Reporter's Comments: Sleep disorder and Quality of life decreased were assessed as not related, as they are secondary to porokeratosis. The benefit-risk relationship of product is not affected by this report.
Eczematous dermatitis
Dupilumab
Test Date: 2024; Test Name: Biopsy; Result Unstructured Data: Two biopsies obtained from the right back and right arm demonstrated cornoid lamellae, consistent with porokeratosis. Both specimens also showed a superficial perivascular and focally lichenoid lymphohistiocytic inflammatory infiltrate a finding most often found in eruptive papular pruritic porokeratosis. Histologic features of porokeratosis showed characteristic cornoid lamella, composed of a thin column of parakeratosis overlying focal loss of the granular layer and dyskeratotic keratinocytes. The adjacent epidermis showed mild acanthosis. A superficial perivascular and interface lymphocytic inflammatory infiltrate was noted in the underlying dermis, most prominent beneath the cornoid lamella; Test Date: 2024; Test Name: RNA in situ hybridization (RISH); Result Unstructured Data: RNA in situ hybridization (RISH) revealed expression of interferon-gamma and interleukin 13, while psoriasis-associated biomarkers interleukin 17 A and nitric oxide synthase 2 were absent. The diagnosis supported a diagnosis of eruptive pruritic papular porokeratosis; Test Date: 2024; Test Name: Physical examination; Result Unstructured Data: Torso, back, and right distal lower extremity after 4 weeks of upadacitinib treatment, demonstrating a significant reduction in both erythema and lesion thickness; Test Date: 202409; Test Name: Physical examination; Result Unstructured Data: Torso, back, and right distal lower extremity prior to treatment with upadacitinib, showing multiple papules and plaques of porokeratosis with pronounced erythema