Age: 52.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Fatigue, Inflammation, Pain in extremity
Clinical narrative: Inflammation; Pain in hand; Fatigue; COVID-19; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INFLAMMATION (Inflammation), PAIN IN EXTREMITY (Pain in hand), the first episode of FATIGUE (Fatigue) and the second episode of FATIGUE (Fatigue) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced the first episode of FATIGUE (Fatigue). On 02-Nov-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INFLAMMATION (Inflammation), PAIN IN EXTREMITY (Pain in hand) and the second episode of FATIGUE (Fatigue). In 2021, COVID-19 (COVID-19) had resolved. At the time of the report, INFLAMMATION (Inflammation) and PAIN IN EXTREMITY (Pain in hand) had not resolved and last episode of FATIGUE (Fatigue) had resolved.            No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 52-year-old male patient, with no reported medical history, treated with co-suspect drug Adalimumab for psoriatic arthritis (start date not reported), who experienced the unexpected non-serious AESI COVID-19. The event occurred within the same year of administration of the 3rd dose of mRNA-1273 vaccine. The event was reported along with the event fatigue. Clinical course and treatment details were not reported. Patient received first two doses of mRNA-1273 vaccine on unknown dates, hence lack of efficacy cannot be concluded for this case. The outcome of event was reported as resolved. Adalimumab for psoriatic arthritis is suggestive of underlying psoriatic arthritis could be considered as a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 52-year-old male patient, with no reported medical history, treated with co-suspect drug Adalimumab for psoriatic arthritis (start date not reported), who experienced the unexpected non-serious AESI COVID-19. The event occurred within the same year of administration of the 3rd dose of mRNA-1273 vaccine. The event was reported along with the event fatigue. Clinical course and treatment details were not reported. Patient received first two doses of mRNA-1273 vaccine on unknown dates, hence lack of efficacy cannot be concluded for this case. The outcome of event was reported as resolved. Adalimumab for psoriatic arthritis is suggestive of underlying psoriatic arthritis could be considered as a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.