Sex: U
Vaccine: COVID19
Symptoms: Acute myeloid leukaemia
Clinical narrative: relapsed AML post mRNA-1273 vaccination; This literature-study case was reported in a literature article and describes the occurrence of ACUTE MYELOID LEUKAEMIA (relapsed AML post mRNA-1273 vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE MYELOID LEUKAEMIA (relapsed AML post mRNA-1273 vaccination) (seriousness criterion medically significant). At the time of the report, ACUTE MYELOID LEUKAEMIA (relapsed AML post mRNA-1273 vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE MYELOID LEUKAEMIA (relapsed AML post mRNA-1273 vaccination) to be related.    No concomitant information were provided. No treatment information reported. Blood specimens were collected from patients prior to the and second vaccine doses (Days 1 and 29) and ~28 days after the second vaccine dose (Day 57) for antibody analyses. Two-step ELISA was performed, measuring IgG responses.SARS-CoV-2 antibody positivity rates were compared using the Fisher exact test or Chi-square test.  Company Comment - This case concerns a patient of unknown age and gender with no relevant medical history of who experienced serious unexpected event of acute myeloid leukaemia. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided nor was provided vaccination start date. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Furthermore, very limited information regarding patient's medical history and concomitant medications was provided. The reporter assessed the event as related to the suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Follow up received by safety 06-Jan-2022 included an Email from two regulatory authorities and contains authors information.; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history of who experienced serious unexpected event of acute myeloid leukaemia. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided nor was provided vaccination start date. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Furthermore, very limited information regarding patient's medical history and concomitant medications was provided. The reporter assessed the event as related to the suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.