Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Malignant melanoma, Rash, Sleep disorder, White blood cell count
Clinical narrative: Might have melanoma spots; White count is 12.3; Depression; Sleep disorder; Rash; This spontaneous case was reported by a consumer and describes the occurrence of MALIGNANT MELANOMA (Might have melanoma spots) in a 73-year-old male 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 IBRUTINIB (IMBRUVICA) for B-cell chronic lymphocytic leukaemia.    The patient's past medical history included Sunburn. Concurrent medical conditions included B-cell chronic lymphocytic leukaemia (Not achieve remission).   On 15-Nov-2018, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram once a day and IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram once a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to at an unspecified dose. In June 2021, the patient experienced DEPRESSION (Depression) and SLEEP DISORDER (Sleep disorder). In 2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced MALIGNANT MELANOMA (Might have melanoma spots) (seriousness criterion medically significant) and WHITE BLOOD CELL DISORDER (White count is 12.3). The patient was treated with MIRTAZAPINE for Sleep disorder, at an unspecified dose and frequency and Surgery (Removed melanoma) for Malignant melanoma. In 2021, DEPRESSION (Depression), SLEEP DISORDER (Sleep disorder) and RASH (Rash) had resolved. At the time of the report, MALIGNANT MELANOMA (Might have melanoma spots) was resolving and WHITE BLOOD CELL DISORDER (White count is 12.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: 12.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included medication for depression.  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 a 73-year-old male patient, with relevant medical condition of B-cell chronic lymphocytic leukaemia, who experienced the unexpected and serious (due to medically significant) event of Malignant melanoma, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Ibrutinib for B-cell chronic lymphocytic leukaemia. Patient had melanoma biopsied and removed from back. No information disclosed about diagnostic tests results. At the time of the report, the event was resolving. Underlying B-cell chronic lymphocytic leukaemia could be a confounding factor for the event. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 73-year-old male patient, with relevant medical condition of B-cell chronic lymphocytic leukaemia, who experienced the unexpected and serious (due to medically significant) event of Malignant melanoma, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Ibrutinib for B-cell chronic lymphocytic leukaemia. Patient had melanoma biopsied and removed from back. No information disclosed about diagnostic tests results. At the time of the report, the event was resolving. Underlying B-cell chronic lymphocytic leukaemia could be a confounding factor for the event. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.