Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Skin cancer
Clinical narrative: COVID-19; Skin cancer; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of SKIN CANCER (Skin cancer) in a 73-year-old 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 product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. On 29-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 07-Jul-2022, the patient experienced COVID-19 (COVID-19). In July 2022, the patient experienced SKIN CANCER (Skin cancer) (seriousness criterion medically significant). At the time of the report, SKIN CANCER (Skin cancer) and COVID-19 (COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Patient had no known allergies. Patient did not took any concomitant drugs.  Patient did not agree to have physician contacted.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not available in the patient's file.  The reporter's causality for the event of skin cancer was not provided and the reporter's causality for the event of COVID-19 was no reasonable possibility with HUMIRA(ADALIMUMAB).  No treatment medications were reported.  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.  Company Comment: This is a spontaneous case concerning a 73-year-old female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Skin cancer and the unexpected, non-serious adverse event of special interest of COVID-19, approximately 8 months after receiving the third dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The events had not resolved at the time of the report. Inappropriate schedule of vaccine administered was also reported as an additional event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-627610 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2022: Follow-up received wherein suspect vaccine and co suspect drug information, event (skin cancer), and reporter's causality added. Narrative description updated. New event added and current condition added.; Sender's Comments: This is a spontaneous case concerning a 73-year-old female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Skin cancer and the unexpected, non-serious adverse event of special interest of COVID-19, approximately 8 months after receiving the third dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The events had not resolved at the time of the report. Inappropriate schedule of vaccine administered was also reported as an additional event. The benefit-risk relationship of mRNA-1273 is not affected by this report.