Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram, Fatigue, Inflammatory marker test, Magnetic resonance imaging
Clinical narrative: FELT A LITTLE SICKLY; WEAK; LOCAL SORENESS IN VACCINATION SITE; TIRED; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (FELT A LITTLE SICKLY), ASTHENIA (WEAK), VACCINATION SITE PAIN (LOCAL SORENESS IN VACCINATION SITE) and FATIGUE (TIRED) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 018A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Joint replacement in 2009, Non-tobacco user, Abstains from alcohol, Joint replacement (FIVE MAJOR), Rheumatoid arthritis in 2020 and Finger osteoarthritis in 2020. Previously administered products included for Drug use for unknown indication: METHOTREXATE; for Rheumatoid arthritis: VIOXX, NAPROXEN and ENBREL. Past adverse reactions to the above products included No adverse event with ENBREL, METHOTREXATE, NAPROXEN and VIOXX. Family history included Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis flare up. Concomitant products included CELECOXIB (CELEBREX) for Osteoarthritis, HYDROXYCHLOROQUINE for Rheumatoid arthritis, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for Supplementation therapy.   In 2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2020, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced MALAISE (FELT A LITTLE SICKLY), ASTHENIA (WEAK), VACCINATION SITE PAIN (LOCAL SORENESS IN VACCINATION SITE) and FATIGUE (TIRED). The patient was treated with SULFASALAZINE at an unspecified dose and frequency. In March 2021, MALAISE (FELT A LITTLE SICKLY), ASTHENIA (WEAK), VACCINATION SITE PAIN (LOCAL SORENESS IN VACCINATION SITE) and FATIGUE (TIRED) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Magnetic resonance imaging: Confirmed new inflammation and degradation of finger joints in the knuckles. In August 2021, Computerised tomogram: Damage on hands - confirmed inflammation, swelling, and degradation of finger joints. In August 2021, Inflammatory marker test: Inflammatory marker decreased. On an unknown date, Magnetic resonance imaging: Showed degradation and swelling.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In August 2021, the patient experienced BLOOD WORK SHOWED THAT INFLAMMATION WAS DOWN. The reporter's causality for the event(s) of FELT A LITTLE SICKLY, LOCAL SORENESS IN VACCINATION SITE, WEAK, TIRED, BLOOD WORK SHOWED THAT INFLAMMATION WAS DOWN and RHEUMATOID ARTHRITIS SYMPTOMS STARTED COMING BACK IN HANDS was not provided. The reporter's causality for the event(s) of DEGRADATION OF FINGER JOINTS with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. 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