Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Skin cancer
Clinical narrative: Skin cancer; Fatigue; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SKIN CANCER (Skin cancer) 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 product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced SKIN CANCER (Skin cancer) (seriousness criterion medically significant), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, SKIN CANCER (Skin cancer) had resolved and FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient received HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB).  It was reported that patient had to have skin cancer removed. The physician said he was not concerned at this point unless it happened again. Patient took Moderna booster and its caused her to have headache chills and fatigued.  The reporter's causality for the event(s) of skin cancer with Humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of fatigue, headache and chills was not 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.  Company Comment: This is a spontaneous case, reported by a consumer, concerning an adult female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Skin cancer, in the context of the 3 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. Patient had received 2-dose primary series of mRNA-1273 vaccine on unknown dates, prior to third mRNA-1273 vaccination. It was reported that patient had to have skin cancer removed by the doctor. Patient also experienced headache, chills and fatigue after the booster dose of mRNA-1273 vaccine. No further details about the clinical course and diagnostic procedures were provided. It was reported that the event Skin cancer had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an adult female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Skin cancer, in the context of the 3 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. Patient had received 2-dose primary series of mRNA-1273 vaccine on unknown dates, prior to third mRNA-1273 vaccination. It was reported that patient had to have skin cancer removed by the doctor. Patient also experienced headache, chills and fatigue after the booster dose of mRNA-1273 vaccine. No further details about the clinical course and diagnostic procedures were provided. It was reported that the event Skin cancer had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.