Sex: F
Vaccine: COVID19, COVID19
Symptoms: Basal cell carcinoma, COVID-19, SARS-CoV-2 test, Tooth fracture
Clinical narrative: BASAL CELL CARCINOMA; CRACKED TOOTH; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of BASAL CELL CARCINOMA (BASAL CELL CARCINOMA) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.    Concurrent medical conditions included Rheumatoid arthritis.   On 04-Jun-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (unknown route) 1 dosage form. On 03-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BASAL CELL CARCINOMA (BASAL CELL CARCINOMA) (seriousness criterion medically significant), TOOTH FRACTURE (CRACKED TOOTH) and COVID-19 (COVID-19). At the time of the report, BASAL CELL CARCINOMA (BASAL CELL CARCINOMA) and TOOTH FRACTURE (CRACKED TOOTH) had not resolved and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Company comment: This is a spontaneous case concerning an adult female patient with Rheumatoid arthritis on treatment with Upadacitinib, who experienced the serious (medically significant) unexpected event basal cell carcinoma and non-serious AESI COVID-19. Basal cell carcinoma started on an unknown date and no other details was provided.  The event COVID-19 occurred "right after" the booster dose of mRNA-1273 (previous primary  vaccination 7 months earlier with single dose of AD26 COVID-19 VACCINE JANSSEN ). A SARS-CoV-2 test was performed with positive result. Clinical course and treatment details were not provided. Upadacitinib was reported as a co-suspect product. Events seriousness captured as per SD. The benefit-risk relationship of mRNA-1273 is not affected by this report No concomitant medication was reported.  Reportedly, patient bit down on a candy and cracked a tooth. Patient had basal cell carcinoma. Patient got COVID right after get her covid booster.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of BASAL CELL CARCINOMA, CRACKED TOOTH and COVID with RINVOQ was not provided.  No treatment information was provided.  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.; Sender's Comments: Company comment: This is a spontaneous case concerning an adult female patient with Rheumatoid arthritis on treatment with Upadacitinib, who experienced the serious (medically significant) unexpected event basal cell carcinoma and non-serious AESI COVID-19. Basal cell carcinoma started on an unknown date and no other details was provided.  The event COVID-19 occurred "right after" the booster dose of mRNA-1273 (previous primary  vaccination 7 months earlier with single dose of AD26 COVID-19 VACCINE JANSSEN ). A SARS-CoV-2 test was performed with positive result. Clinical course and treatment details were not provided. Upadacitinib was reported as a co-suspect product. Events seriousness captured as per SD. The benefit-risk relationship of mRNA-1273 is not affected by this report.