Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Diabetes mellitus, General physical health deterioration, Renal disorder
Clinical narrative: Diabetes; Kidney disorder; General physical health deterioration; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (Diabetes) in a 64-year-old female patient who received mRNA-1273 (Spikevax) 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.   In January 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF 40 mg,1 in 2 week. In 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant), RENAL DISORDER (Kidney disorder) and GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration). At the time of the report, DIABETES MELLITUS (Diabetes), RENAL DISORDER (Kidney disorder) and GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration) outcome was unknown and COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 64-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Rheumatoid Arthritis, who experienced the unexpected, serious (medically significant) event of diabetes mellitus, the unexpected, non-serious of COVID-19, and other unexpected, non-serious events. The start dates of the event diabetes mellitus and the non-serious events renal disorder and general physical health deterioration were not provided. The administration date of Humira was not provided and the vaccination date of the first dose of the mRNA-1273 vaccine was reported as unspecified date in Jan2022. Hence, the onset latency could not be assessed. The event COVID-19 occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided, hence, the onset latency could not be assessed. The event COVID-19 occurred unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the vaccination date was reported as unspecified date in Jan2022 and the event onset date was reported as unspecified date in 2022, hence, the onset latency could not be assessed. Treatment information was not provided. The history of co-suspect administration of Humira remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 64-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Rheumatoid Arthritis, who experienced the unexpected, serious (medically significant) event of diabetes mellitus, the unexpected, non-serious of COVID-19, and other unexpected, non-serious events. The start dates of the event diabetes mellitus and the non-serious events renal disorder and general physical health deterioration were not provided. The administration date of Humira was not provided and the vaccination date of the first dose of the mRNA-1273 vaccine was reported as unspecified date in Jan2022. Hence, the onset latency could not be assessed. The event COVID-19 occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided, hence, the onset latency could not be assessed. The event COVID-19 occurred unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the vaccination date was reported as unspecified date in Jan2022 and the event onset date was reported as unspecified date in 2022, hence, the onset latency could not be assessed. Treatment information was not provided. The history of co-suspect administration of Humira remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.