Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diabetes mellitus inadequate control, Fall, Skin abrasion
Clinical narrative: Skin abrasion/SCRAPED NOSE; FALL; painful joints/SORE IN SHOULDERS AND ELBOWS; Loss of control of blood sugar/UNCONTROLLED SUGAR LEVELS; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (Loss of control of blood sugar/UNCONTROLLED SUGAR LEVELS) in an elderly 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 products included non-company products ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis and ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis and Diabetes.   On 04-Sep-2014, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.8ML(40 Milligram, Solution for injection). In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third 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) 1 in 2 wk, 40MG/0.4ML(40 Milligram, Solution for injection). In November 2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (Loss of control of blood sugar/UNCONTROLLED SUGAR LEVELS) (seriousness criterion medically significant). In May 2022, the patient experienced SKIN ABRASION (Skin abrasion/SCRAPED NOSE), FALL (FALL) and ARTHRALGIA (painful joints/SORE IN SHOULDERS AND ELBOWS). The patient was treated with INSULIN for Loss of control of blood sugar, at an unspecified dose and frequency and INSULIN GLARGINE (LANTUS) at an unspecified dose and frequency. At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (Loss of control of blood sugar/UNCONTROLLED SUGAR LEVELS) had not resolved and SKIN ABRASION (Skin abrasion/SCRAPED NOSE), FALL (FALL) and ARTHRALGIA (painful joints/SORE IN SHOULDERS AND ELBOWS) was resolving.            No concomitant medication information provided  The reporter alternative etiology for the event uncontrolled sugar levels was reported as reaction to COVID-19 vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the packaging was discarded.  Company Comment: This spontaneous case concerns an elderly (age not provided), female patient with relevant medical history Diabetes and Psoriatic Arthritis, and history of co-suspect administration of two doses of Humira (adalimumab), who experienced the unexpected, serious (medically significant) event of diabetes mellitus inadequate control and other associated non-serious events. The event diabetes mellitus inadequate control occurred on an unspecified date in Nov2021 after receiving the third dose of the mRNA-1273 vaccine on an unspecified date in Nov2021. The non-serious events occurred on unspecified dates in May2022 after receiving the third dose of the mRNA-1273 vaccine on an unspecified date in Nov2021. The patient was treated with insulin and Lantus (insulin glargine) of unspecified dosage, frequency and duration. The event diabetes mellitus inadequate control had not resolved, while the non-serious events were resolving at the time of the report. The medical history of Diabetes remains a confounder for the event diabetes mellitus inadequate control. The medical history of Psoriatic Arthritis remains a confounder for the non-serious event arthralgia. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly (age not provided), female patient with relevant medical history Diabetes and Psoriatic Arthritis, and history of co-suspect administration of two doses of Humira (adalimumab), who experienced the unexpected, serious (medically significant) event of diabetes mellitus inadequate control and other associated non-serious events. The event diabetes mellitus inadequate control occurred on an unspecified date in Nov2021 after receiving the third dose of the mRNA-1273 vaccine on an unspecified date in Nov2021. The non-serious events occurred on unspecified dates in May2022 after receiving the third dose of the mRNA-1273 vaccine on an unspecified date in Nov2021. The patient was treated with insulin and Lantus (insulin glargine) of unspecified dosage, frequency and duration. The event diabetes mellitus inadequate control had not resolved, while the non-serious events were resolving at the time of the report. The medical history of Diabetes remains a confounder for the event diabetes mellitus inadequate control. The medical history of Psoriatic Arthritis remains a confounder for the non-serious event arthralgia. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.