Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Keratoacanthoma, Physical examination
Clinical narrative: Solitary Eruptive Keratoacanthoma at the site of COVID-19 vaccine administration; This literature-non-study case was reported in a literature article and describes the occurrence of KERATOACANTHOMA (Solitary Eruptive Keratoacanthoma at the site of COVID-19 vaccine administration) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.      Concurrent medical conditions included Osteoarthritis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced KERATOACANTHOMA (Solitary Eruptive Keratoacanthoma at the site of COVID-19 vaccine administration) (seriousness criterion medically significant). At the time of the report, KERATOACANTHOMA (Solitary Eruptive Keratoacanthoma at the site of COVID-19 vaccine administration) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy skin: Showed crateriform, atypical proliferation of keratinocytes with prominent pink, glassy cytoplasm, consistent with a squamous cell carcinoma, keratoacanthomatous type. and confirmed complete excision of residual squamous cell   carcinoma, keratoacanthomatous type.. In 2021, Physical examination. Overlying the right deltoid was a 1.5 cm firm, pink nodule with crateriform center..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Within a week of receiving this third booster dose, the patient noted development of a new skin lesion in exactly the same location where the third shot had been injected. He did not note any bleeding or pruritus. There was no history of fevers, night sweats, fatigue, or weight loss. The patient had not experienced any other symptoms following administration of the vaccine. The patient had no other chronic medical conditions. He neither have allergies, nor taking any medications. The patient did not have any prior history of skin cancer or inflammatory skin disease. After a month, patient presented for surgical excision of the keratoacanthoma. The lesion was persistent and had increased in size to 1.7 cm by 1.4 cm.  No treatment medications were provided.  Company comment:  This is a literature-non-study case concerning a 66-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Keratoacanthoma. The event began within one weeks after the administration of the third dose of mRNA-1273 vaccine, nine and 10 months after the second and first dose, respectevely. The patient received the first two doses of mRNA-1273 vaccine with no adverse events reported and one week after the third dose (all administered on the right arm) the patient developed a skin lesion at injection site. About 6 weeks after vaccination, a surgical excision was made and histologic examination confirmed a crateriform, atypical proliferation of keratinocytes with prominent pink, glassy cytoplasm, consistent with a squamous cell carcinoma, keratoacanthomatous type. and local reiterate skin injury is a risk factor to developed an a squamous cell carcinoma.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2023: Follow up received by safety on 08-Dec-2023 has Email received and contains significant information: Reporter added, Literature citation details added, Medical history added, suspect details and regimens added, event verbatim updated, narrative updated.