Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Joint swelling, Overweight, Pain
Clinical narrative: LOWER BACK PAIN; ACHINESS FOLLOWING VACCINES; HAIR LOSS; Weight gain; Depression; OVERWEIGHT; SWOLLEN ANKLES; JOINT PAIN; COVID-19; FATIGUE AFTER ALL COVID VACCINE; HEADACHES FOLLOWING ALL COVID VACCINES; SORE ARM AFTER COVID VACCINE BOOSTER DOSE; This spontaneous case was reported by a consumer and describes the occurrence of OVERWEIGHT (OVERWEIGHT), JOINT SWELLING (SWOLLEN ANKLES), COVID-19 (COVID-19), BACK PAIN (LOWER BACK PAIN) and PAIN (ACHINESS FOLLOWING VACCINES) in a 50-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 products included non-company products ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis and METHOTREXATE for an unknown indication.    The patient's past medical history included Operation NOS. Concurrent medical conditions included Psoriatic arthritis and Rheumatoid arthritis.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-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) (unknown route) Citrate free and METHOTREXATE (unknown route) at an unspecified dose. In 2021, the patient experienced FATIGUE (FATIGUE AFTER ALL COVID VACCINE), HEADACHE (HEADACHES FOLLOWING ALL COVID VACCINES) and VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE BOOSTER DOSE). On 04-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced OVERWEIGHT (OVERWEIGHT), JOINT SWELLING (SWOLLEN ANKLES), BACK PAIN (LOWER BACK PAIN), PAIN (ACHINESS FOLLOWING VACCINES), ALOPECIA (HAIR LOSS), WEIGHT INCREASED (Weight gain), DEPRESSION (Depression) and ARTHRALGIA (JOINT PAIN). At the time of the report, OVERWEIGHT (OVERWEIGHT), JOINT SWELLING (SWOLLEN ANKLES), COVID-19 (COVID-19), BACK PAIN (LOWER BACK PAIN), PAIN (ACHINESS FOLLOWING VACCINES), ALOPECIA (HAIR LOSS), WEIGHT INCREASED (Weight gain), DEPRESSION (Depression), FATIGUE (FATIGUE AFTER ALL COVID VACCINE), HEADACHE (HEADACHES FOLLOWING ALL COVID VACCINES), VACCINATION SITE PAIN (SORE ARM AFTER COVID VACCINE BOOSTER DOSE) and ARTHRALGIA (JOINT PAIN) outcome was unknown.            No concomitant products were reported. On unknown dates, the patient experienced surgery, overweight, swollen ankles, flare, weight gain, depression, did not felt humira was helping to psoriatic arthritis, lower back pain, achiness following vaccines, hair loss and joint pain in various areas. In 2021, the patient experienced fatigue after all covid vaccine, sore arm after covid vaccine booster dose and headaches following all covid vaccines. on 04-Jan-2022, the patient experienced covid 19. moderna covid-19 vaccine (elasomeran) and methotrexate were also considered suspect. The patients mention joint pain that she relates to being a bit overweight. sore arm and fatigue after booster. She had achiness following vaccines. lower back pain. states that she did not felt like humira was helping her psoriatic arthritis. She had temporary minor aches, headaches, fatigue following all vaccines. it was unknown if patient was enrolled in a covid-19 vaccine trial.  No treatment information was reported by the reporter.  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.   This case was linked to MOD-2022-624144 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2022: Live significant follow up - dose detail updated, event added On 28-Mar-2022: Significant follow up appended. On 06-May-2022: Live significant Follow up On 06-Jul-2022: Significant follow-up received includes updated event information, narrative description and  laboratory/diagnostic procedures received.; Sender's Comments: This spontaneous case concerns a 50-year-old female patient on concomitant Adalimumab and Methotrexate for Psoriatic arthritis and Rheumatoid arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19, that occurred 2 months and 6 days after receiving booster dose of mRNA-1273 vaccine given as third in the COVID-19 vaccination series.  SARS-CoV-2 test was not reported. Treatment details and clinical course were undisclosed. Patient previously received a 2-dose primary series mRNA-1273 vaccine given 28 days apart, the last dose of which was administered approximately 9 months prior to current vaccine.  The concomitant Adalimumab and Methotrexate are immunosuppressants that may slow down the immune system and may lower the immune response to mRNA-1273 vaccine leading to a predisposition to infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.