Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Leukaemia, Peripheral swelling, Rash erythematous
Clinical narrative: SWELLING ON ARM; Rash over arms/RASH ON ARM and REDNESS ON ARM; Leukemia; This spontaneous case was reported by a consumer and describes the occurrence of LEUKAEMIA (Leukemia) 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 Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 21-Feb-2021, the patient experienced LEUKAEMIA (Leukemia) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (SWELLING ON ARM) and RASH ERYTHEMATOUS (Rash over arms/RASH ON ARM and REDNESS ON ARM). At the time of the report, LEUKAEMIA (Leukemia) outcome was unknown and PERIPHERAL SWELLING (SWELLING ON ARM) and RASH ERYTHEMATOUS (Rash over arms/RASH ON ARM and REDNESS ON ARM) had resolved.            Co suspect drug HUMIRA Dose description was reported as Solution for injection in pre-filled pen, Citrate free.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient was reported that she had COVID arm, redness, rash and swelling that lasted about two weeks.  The reporter causality for the events EUKAEMIA (Leukemia), PERIPHERAL SWELLING (SWELLING ON ARM), RASH (Rash over arms/RASH ON ARM), ERYTHEMA (Erythema of extremities) and VACCINATION SITE ERYTHEMA (REDNESS ON ARM) were not reported with Humira.   No concomitant medications were reported.  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 spontaneous case concerns a 73-year-old female patient, with relevant medical history of Crohn's disease treated with co-suspect Adalimumab, who experienced the unexpected serious (medically significant) event of Leukemia that occurred 5 days after receiving the 2nd dose of mRNA-1273 vaccine along with other non-serious event. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Patient received primary series of mRNA-1273 vaccine 28 days apart, and 3rd dose of mRNA-1273 vaccine was received 6 months later. Co-suspect Adalimumab remain as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-623896 (Patient Link).; Sender's Comments: This spontaneous case concerns a 73-year-old female patient, with relevant medical history of Crohn's disease treated with co-suspect Adalimumab, who experienced the unexpected serious (medically significant) event of Leukemia that occurred 5 days after receiving the 2nd dose of mRNA-1273 vaccine along with other non-serious event. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Patient received primary series of mRNA-1273 vaccine 28 days apart, and 3rd dose of mRNA-1273 vaccine was received 6 months later. Co-suspect Adalimumab remain as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.