Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diabetes mellitus, Headache, Osteoarthritis
Clinical narrative: DIABETIC; PSORIATIC ARTHRITIS FLARE; OSTEOARTHRITIS IN BOTH KNEES; ACHINESS; HIP PAIN; CHILLS; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (DIABETIC) and PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE) in a 72-year-old patient of an unknown gender 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.    Concurrent medical conditions included Psoriatic arthritis.   On 08-Dec-2009, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF,Solution for injection in pre-filled pen. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to CF, Solution for injection in pre-filled pen. In 2021, the patient experienced CHILLS (CHILLS) and HEADACHE (HEADACHE). On an unknown date, the patient experienced DIABETES MELLITUS (DIABETIC) (seriousness criterion medically significant), PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE) (seriousness criterion medically significant), OSTEOARTHRITIS (OSTEOARTHRITIS IN BOTH KNEES), PAIN (ACHINESS) and ARTHRALGIA (HIP PAIN). At the time of the report, DIABETES MELLITUS (DIABETIC), PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE), OSTEOARTHRITIS (OSTEOARTHRITIS IN BOTH KNEES) and ARTHRALGIA (HIP PAIN) had not resolved and PAIN (ACHINESS), CHILLS (CHILLS) and HEADACHE (HEADACHE) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the event(s) of OSTEOARTHRITIS IN BOTH KNEES, DIABETIC, HEADACHE and ACHINESS with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporters causality for the events of DIFFICULTY STANDING FOR LONG PERIODS OF TIME and PSORIATIC ARTHRITIS FLARE with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporters causality for the events of CHILLS was not provided.  No treatment medication 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 an elderly patient aged 72 years of unknown gender with reported concurrent condition of Psoriatic arthritis on Humira, experienced unexpected serious (medically significant) events of Psoriatic arthropathy (reported as Psoriatic arthropathy aggravated) and Diabetes mellitus that occurred on unknown dates in the context of mRNA-1273 vaccination. Patient had received initial two doses at an interval of one month and 3rd dose eight months later. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not recovered at the time of report. Relevant medical history remains a confounder to the event Psoriatic arthropathy aggravated. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2022: Follow up received contains significant information start date of Moderna suspect dose was updated, dose details were added for Humira suspect and event(ache) was added.; Sender's Comments: This spontaneous case concerns an elderly patient aged 72 years of unknown gender with reported concurrent condition of Psoriatic arthritis on Humira, experienced unexpected serious (medically significant) events of Psoriatic arthropathy (reported as Psoriatic arthropathy aggravated) and Diabetes mellitus that occurred on unknown dates in the context of mRNA-1273 vaccination. Patient had received initial two doses at an interval of one month and 3rd dose eight months later. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not recovered at the time of report. Relevant medical history remains a confounder to the event Psoriatic arthropathy aggravated. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.