Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Exposure to SARS-CoV-2, Incorrect dose administered
Clinical narrative: Exposure to COVID-19; Inappropriate dose of drug administered; Diabetes; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (Diabetes) in a 67-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) for Rheumatoid arthritis.    No Medical History information was reported.   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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In July 2022, the patient experienced DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered). At the time of the report, DIABETES MELLITUS (Diabetes), EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered) outcome was unknown.            No concomitant medications were reported. Patient had experienced COVID exposure and received moderna COVID vaccine three full doses rather than three and half. Booster dose of MODERNA COVID-19 VACCINE was 1 in 1 D. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  Company comment: This spontaneous case concerns a 67-years-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Diabetes mellitus that occurred in the context of mRNA-1273 vaccination and after the Co-suspect non-company product of ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Latency cannot be assessed since vaccination date was not disclosed. The Clinical course, and treatment details were not provided, and the event outcome was unknown. Patient's Co-suspect non-company product of ADALIMUMAB (HUMIRA) for Rheumatoid arthritis could be the confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 67-years-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Diabetes mellitus that occurred in the context of mRNA-1273 vaccination and after the Co-suspect non-company product of ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Latency cannot be assessed since vaccination date was not disclosed. The Clinical course, and treatment details were not provided, and the event outcome was unknown. Patient's Co-suspect non-company product of ADALIMUMAB (HUMIRA) for Rheumatoid arthritis could be the confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.