Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Body temperature, Body temperature decreased, Diabetes mellitus, Renal disorder
Clinical narrative: Diabetes; Kidney disorder; Body temperature decreased; Tick bite; COVID-19 antibody test positive; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (Diabetes) in a 59-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 Psoriatic arthritis.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-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) at an unspecified dose. In December 2020, the patient experienced ARTHROPOD BITE (Tick bite) and SARS-COV-2 ANTIBODY TEST POSITIVE (COVID-19 antibody test positive). On 26-Oct-2021, the patient experienced BODY TEMPERATURE DECREASED (Body temperature decreased). On an unknown date, the patient experienced DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant) and RENAL DISORDER (Kidney disorder). On 26-Oct-2021, BODY TEMPERATURE DECREASED (Body temperature decreased) had resolved. At the time of the report, DIABETES MELLITUS (Diabetes) and RENAL DISORDER (Kidney disorder) had not resolved, ARTHROPOD BITE (Tick bite) outcome was unknown and SARS-COV-2 ANTIBODY TEST POSITIVE (COVID-19 antibody test positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 antibody test: (Positive) positive. On 26-Oct-2021, Body temperature: Low/Freezing in body temperature.    Company Comment : This spontaneous case concerns a 59-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Psoriatic Arthritis, who experienced the unexpected, serious (medically significant) event of diabetes mellitus and other unexpected, non-serious events. The non-serious events arthropod bite and SARS-CoV-2 antibody test positive occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided and the event onset dates were reported as unspecified dates in Dec2020, hence, the onset latency could not be assessed. The events occurred approximately 1 to 2 months before receiving the first dose of the mRNA-1273 vaccine. Of note, the outcome of the event arthropod bite was unknown at the time the patient received the first dose of the mRNA-1273 vaccine. The non-serious event body temperature decreased 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 occurred approximately 8 months after receiving the first dose of the mRNA-1273 vaccine. Treatment information was not provided. However, the event had resolved on the same day. The start dates of the event diabetes mellitus and the non-serious event renal disorder were not provided, hence, the onset latency could not be assessed. Treatment information was also not provided. The events had not resolved at the time of the report. 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.     Formulation of Humira was reported as Solution for injection in pre-filled pen.  No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was 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.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow-up received contains non-significant information.; Sender's Comments: This spontaneous case concerns a 59-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Psoriatic Arthritis, who experienced the unexpected, serious (medically significant) event of diabetes mellitus and other unexpected, non-serious events. The non-serious events arthropod bite and SARS-CoV-2 antibody test positive occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided and the event onset dates were reported as unspecified dates in Dec2020, hence, the onset latency could not be assessed. The events occurred approximately 1 to 2 months before receiving the first dose of the mRNA-1273 vaccine. Of note, the outcome of the event arthropod bite was unknown at the time the patient received the first dose of the mRNA-1273 vaccine. The non-serious event body temperature decreased 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 occurred approximately 8 months after receiving the first dose of the mRNA-1273 vaccine. Treatment information was not provided. However, the event had resolved on the same day. The start dates of the event diabetes mellitus and the non-serious event renal disorder were not provided, hence, the onset latency could not be assessed. Treatment information was also not provided. The events had not resolved at the time of the report. 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.