Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Physical examination
Clinical narrative: Vaccine-induced lichenoid eruption; Peptic ulcer; Herpes zoster; This literature-non-study case was reported in a literature article and describes the occurrence of LICHENOID KERATOSIS (Vaccine-induced lichenoid eruption) and PEPTIC ULCER (Peptic ulcer) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: None. Concurrent medical conditions included Prostate cancer.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LICHENOID KERATOSIS (Vaccine-induced lichenoid eruption) (seriousness criterion hospitalization). In 2021, the patient experienced PEPTIC ULCER (Peptic ulcer) (seriousness criterion medically significant) and HERPES ZOSTER (Herpes zoster). The patient was hospitalized on sometime in July 2021 due to LICHENOID KERATOSIS. The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) (intravenous) from July 2021 to July 2021 at an unspecified dose and frequency; PREDNISONE (oral) from 2021 to 2021 at an unspecified dose and frequency; ACITRETIN at an unspecified dose and frequency and ETRETINATE at a dose of 30 milligram once a day. In October 2021, LICHENOID KERATOSIS (Vaccine-induced lichenoid eruption) had resolved and PEPTIC ULCER (Peptic ulcer) and HERPES ZOSTER (Herpes zoster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Biopsy skin: showed typical features of lichen planus (LP) at the end of the June. On 02-Sep-2021, Histology: Histopathologic examination of skin biopsies from the affected sites on the posterior aspect of the left thigh satisfied the criteria for lichen planus.There was a bandlike infiltrate associated with wedge-shaped hypergranulosis. On 02-Sep-2021, Physical examination: revealed characteristic lesions of LP in a generalized distribution, but most severely involved at the upper and lower extremities. Numerous violaceous papules and plaques on the posterior aspect of the thigh and proximal leg.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LICHENOID KERATOSIS (Vaccine-induced lichenoid eruption) to be related. No further causality assessments were provided for PEPTIC ULCER (Peptic ulcer) and HERPES ZOSTER (Herpes zoster).    Concomitant medications were not reported.  The patient began to experience moderate pruritus in the axillae and groin approximately 3 weeks after the second vaccination. A papular eruption then appeared and involved the dorsa of the hands, wrists and quickly spread to the back, buttocks and thighs. The eruption became more generalized and the itching was more severe.  The patient was then hospitalized and treatment was started, which was complicated by the development of herpes zoster and peptic ulcer disease.  The patient presented for dermatologic evaluation on 2 September and reported generalized itching. The patient was treated with oral antihistamines, narrow band ultraviolet B phototherapy sessions and etretinate 30 mg daily. After 2 weeks of therapy, patient began to experience decreased pruritus and a gradual clearing of the lesions. By the end of October, the eruption had resolved.  Author reviewed patients who presented with vaccine induced lichenoid eruption (V-ILE). The spectrum of clinical and histopathologic findings was discussed with emphasis on the subset whose lesions manifested in embryologic fusion lines termed lines of Blaschko. This rare Blaschkoid distribution appeared in seven of the 46 patients studied. Of interest, all seven were linked to the mRNA COVID-19 vaccines.  Authors concluded that they believe that all lichenoid eruptions should be approached with a heightened index of suspicion and patients should be specifically questioned with regards to their vaccination history. When diagnosed early in its course, V-ILE is easily treated and resolves quickly in almost all patients with or without hyperpigmentation. Additional investigative studies regarding its immunopathology and inflammatory signaling pathways might offer insight into other Th1-driven autoimmune phenomena related to COVID-19 vaccination.  Company Comment: This is a literature non-study case concerning an 81-year-old, male patient with a concurrent medical conditions of Prostate cancer, who experienced the serious (due to medically significant) unexpected, event of lichenoid keratosis (reported as Vaccine-induced lichenoid eruption), the serious (due to medically significant) unexpected event of Peptic ulcer and the non-serious unexpected event of Herpes zoster. The patient had no history of hepatitis C or hepatitis B.  The patient began to experience moderate pruritus in the axillae and groin approximately 3 weeks after the second vaccination. A papular eruption then appeared and involved the dorsa of the hands, wrists and quickly spread to the back, buttocks and thighs. The eruption became more generalized and the itching was more severe. The patient was then hospitalized and treatment was started, which was complicated by the development of herpes zoster and peptic ulcer disease. The patient presented for dermatologic evaluation on 2 September and reported generalized itching. The patient was treated with oral antihistamines, narrow band ultraviolet B phototherapy sessions and etretinate 30 mg daily. After 2 weeks of therapy, patient began to experience decreased pruritus and a gradual clearing of the lesions. By the end of October, the eruption had resolved. The event lichenoid keratosis occurred approximately 2 weeks after the second dose of mRNA-1273 vaccine. The events peptic ulcer and herpes zoster occurred after the second dose of mRNA-1273 vaccine (dates not provided). Relevant diagnostic tests included skin biopsy that showed typical features of lichen planus (LP) at the end of the June. On 02-Sep-2021 the Histopathologic examination of skin biopsies from the affected sites on the posterior aspect of the left thigh satisfied the criteria for lichen planus. There was a bandlike infiltrate associated with wedge-shaped hypergranulosis. On 02-Sep-2021, Physical examination revealed characteristic lesions of LP in a generalized distribution, but most severely involved at the upper and lower extremities. Numerous violaceous papules and plaques on the posterior aspect of the thigh and proximal leg. The patient was treated with methylprednisolone sodium succinate (solumedrol) (intravenous), prednisone (oral), acitretin and etretinate. The outcome of the event lichenoid keratosis was reported as reported as resolved. The outcome of the events peptic ulcer and herpes zoster was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-714628 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2023: Follow up received by safety on 10-Mar-2023 has email with full text article and contains significant information: Reporter information, literature information, medical history, lab data, suspect details, treatment, event outcome and narrative were updated.; Sender's Comments: Company Comment: This is a literature non-study case concerning an 81-year-old, male patient with a concurrent medical conditions of Prostate cancer, who experienced the serious (due to medically significant) unexpected, event of lichenoid keratosis (reported as Vaccine-induced lichenoid eruption), the serious (due to medically significant) unexpected event of Peptic ulcer and the non-serious unexpected event of Herpes zoster. The patient had no history of hepatitis C or hepatitis B.  The patient began to experience moderate pruritus in the axillae and groin approximately 3 weeks after the second vaccination. A papular eruption then appeared and involved the dorsa of the hands, wrists and quickly spread to the back, buttocks and thighs. The eruption became more generalized and the itching was more severe. The patient was then hospitalized and treatment was started, which was complicated by the development of herpes zoster and peptic ulcer disease. The patient presented for dermatologic evaluation on 2 September and reported generalized itching. The patient was treated with oral antihistamines, narrow band ultraviolet B phototherapy sessions and etretinate 30 mg daily. After 2 weeks of therapy, patient began to experience decreased pruritus and a gradual clearing of the lesions. By the end of October, the eruption had resolved. The event lichenoid keratosis occurred approximately 2 weeks after the second dose of mRNA-1273 vaccine. The events peptic ulcer and herpes zoster occurred after the second dose of mRNA-1273 vaccine (dates not provided). Relevant diagnostic tests included skin biopsy that showed typical features of lichen planus (LP) at the end of the June. On 02-Sep-2021 the Histopathologic examination of skin biopsies from the affected sites on the posterior aspect of the left thigh satisfied the criteria for lichen planus. There was a bandlike infiltrate associated with wedge-shaped hypergranulosis. On 02-Sep-2021, Physical examination revealed characteristic lesions of LP in a generalized distribution, but most severely involved at the upper and lower extremities. Numerous violaceous papules and plaques on the posterior aspect of the thigh and proximal leg. The patient was treated with methylprednisolone sodium succinate (solumedrol) (intravenous), prednisone (oral), acitretin and etretinate. The outcome of the event lichenoid keratosis was reported as reported as resolved. The outcome of the events peptic ulcer and herpes zoster was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-714628:69-year-old man (Master case)