Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Type 2 diabetes mellitus
Clinical narrative: Type 2 diabetes mellitus; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TYPE 2 DIABETES MELLITUS (Type 2 diabetes mellitus) in a 48-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Type 2 diabetes mellitus since 2018 and Plaque psoriasis (Moderate to severe ).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced TYPE 2 DIABETES MELLITUS (Type 2 diabetes mellitus) (seriousness criterion medically significant) and FATIGUE (Fatigue). At the time of the report, TYPE 2 DIABETES MELLITUS (Type 2 diabetes mellitus) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Patients reported non-serious events type two diabetes and fatigue due to vaccination with SKYRIZI (RISANKIZUMAB).   On an unknown date, the patient experienced fatigue due to vaccination. In 2018, the patient experienced type two diabetes. On unknown dates, type two diabetes and fatigue due to vaccination resolved. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date patient received dose of COVID-19 Vaccine manufactured by Moderna. The reporter's causality for the event(s) of type two diabetes and fatigue due to vaccination with Skyrizi(risankizumab) was no reasonable possibility.  Treatment information 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 spontaneous case concerns a female patient aged 48 years with relevant medical history of diabetes mellitus reported, who experienced the unexpected serious (medically significant) event of Type 2 diabetes mellitus that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. She also had non serious event of Fatigue. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event was resolved at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a female patient aged 48 years with relevant medical history of diabetes mellitus reported, who experienced the unexpected serious (medically significant) event of Type 2 diabetes mellitus that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. She also had non serious event of Fatigue. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event was resolved at the time of report. Relevant medical history remains a confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement