Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Weakness after second vaccine of covid; Bone on Bone; Achiness after second vaccination of covid; Pains in hand and toes, fingers; Pain in hip; Diabetes; 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) injection for Psoriatic arthritis and Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe) and Psoriatic arthritis.   On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Nov-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) Citrate free. In 2019, the patient experienced DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (Weakness after second vaccine of covid), OSTEOARTHRITIS (Bone on Bone), PAIN (Achiness after second vaccination of covid), PAIN IN EXTREMITY (Pains in hand and toes, fingers) and ARTHRALGIA (Pain in hip). The patient was treated with METFORMIN for Diabetes, at an unspecified dose and frequency and GLIPIZIDE for Diabetes, at an unspecified dose and frequency. At the time of the report, DIABETES MELLITUS (Diabetes), ASTHENIA (Weakness after second vaccine of covid), OSTEOARTHRITIS (Bone on Bone) and PAIN (Achiness after second vaccination of covid) outcome was unknown and PAIN IN EXTREMITY (Pains in hand and toes, fingers) and ARTHRALGIA (Pain in hip) had not resolved.            No concomitant and treatment medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira(adalimumab): The reporter's causality for the event(s) of weakness after second vaccine of Covid, bone on bone, diabetes, pains in hips, pains in hand and toes, fingers, and achiness after second vaccination of Covid was not provided.  The formulation for HUMIRA was reported as Solution for injection in pre-filled pen.  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 59 year old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Diabetes mellitus, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the first dose with the same vaccine about 35 days ago with no reported adverse events. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 59 year old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Diabetes mellitus, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the first dose with the same vaccine about 35 days ago with no reported adverse events. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.