Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Genital burning sensation, Polyp, Pruritus genital, Skin cancer
Clinical narrative: Skin cancer; Polyp; Genital burning sensation; Genital itching; This spontaneous case was reported by a consumer and describes the occurrence of SKIN CANCER (Skin cancer), POLYP (Polyp), GENITAL BURNING SENSATION (Genital burning sensation) and PRURITUS GENITAL (Genital itching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Alcohol use, Drug allergy, Penicillin allergy and Crohn's disease. Concomitant products included LISINOPRIL, OMEPRAZOLE, MESALAZINE (APRISO) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free (40 mg,1 in 2 wk). On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free (40 mg,1 in 2 wk). On 26-Apr-2021, the patient experienced SKIN CANCER (Skin cancer) (seriousness criterion medically significant). In 2021, the patient experienced POLYP (Polyp) (seriousness criterion medically significant), GENITAL BURNING SENSATION (Genital burning sensation) (seriousness criterion medically significant) and PRURITUS GENITAL (Genital itching) (seriousness criterion medically significant). On 18-Jan-2022, SKIN CANCER (Skin cancer) had resolved with sequelae. At the time of the report, POLYP (Polyp) had resolved and GENITAL BURNING SENSATION (Genital burning sensation) and PRURITUS GENITAL (Genital itching) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Biopsy: Unknown.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  NO ILLICIT DRUG USE CROHN'S DISEASE.  No concomitant medication was provided by reporter. No treatment medication was provided by reporter.  Company comment:  This spontaneous case concerns a 58 year old female patient with concurrent condition of Crohn s disease, who experienced the unexpected serious (medically significant) events of Skin cancer (on the shin/leg), about 1 month and 13 days after;  Polyp, Genital burning sensation and Pruritus genital, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient underwent skin biopsy, however its result was not disclosed in the report. The patient received the second dose with the same vaccine as per the recommended schedule. The event polyp resolved ; skin cancer resolved with sequelae; Genital burning sensation and Pruritus genital had not resolved. No information on detailed clinical course, reports of relevant investigations was available in the report. Co-suspect adalimumab could be a risk factor for the event Skin cancer. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2022: Significant live follow up (event information, reporter opinion of causality, company opinion ofcausality, company alternative etiology, suspect drug information, narrative description updated); Sender's Comments: This spontaneous case concerns a 58 year old female patient with concurrent condition of Crohn s disease, who experienced the unexpected serious (medically significant) events of Skin cancer (on the shin/leg), about 1 month and 13 days after;  Polyp,  Genital burning sensation and Pruritus genital, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient underwent skin biopsy, however its result was not disclosed in the report. The patient received the second dose with the same vaccine as per the recommended schedule. The event polyp resolved ; skin cancer resolved with sequelae; Genital burning sensation and Pruritus genital had not resolved. No information on detailed clinical course, reports of relevant investigations was available in the report. Co-suspect adalimumab could be a risk factor for the event Skin cancer. The benefit-risk relationship of mRNA-1273 is not affected by this report.