Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Back pain, Depression, Fatigue, Headache
Clinical narrative: Lower back pain; Overweight/Weight gain; Depression; Hairloss; Did not felt Humira was helping to PSORIATIC ARTHRITIS/flare/Condition aggravated; Vaccination site pain/achiness following vaccines/Minor aches; Covid-19 after bothe the doses of vaccine; Headaches; Fatigue after all covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Did not felt Humira was helping to PSORIATIC ARTHRITIS/flare/Condition aggravated) 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) solution for injection for Rheumatoid arthritis and Psoriatic arthritis and METHOTREXATE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis and Psoriatic 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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK,Citrate free On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK,Citrate free. and METHOTREXATE (unknown route) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue after all covid vaccine) and HEADACHE (Headaches). On 04-Jan-2022, the patient experienced VACCINATION FAILURE (Covid-19 after bothe the doses of vaccine). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Did not felt Humira was helping to PSORIATIC ARTHRITIS/flare/Condition aggravated) (seriousness criterion medically significant), BACK PAIN (Lower back pain), WEIGHT INCREASED (Overweight/Weight gain), DEPRESSION (Depression), ALOPECIA (Hairloss) and VACCINATION SITE PAIN (Vaccination site pain/achiness following vaccines/Minor aches). At the time of the report, PSORIATIC ARTHROPATHY (Did not felt Humira was helping to PSORIATIC ARTHRITIS/flare/Condition aggravated), VACCINATION FAILURE (Covid-19 after bothe the doses of vaccine), BACK PAIN (Lower back pain), WEIGHT INCREASED (Overweight/Weight gain), DEPRESSION (Depression), ALOPECIA (Hairloss), FATIGUE (Fatigue after all covid vaccine), VACCINATION SITE PAIN (Vaccination site pain/achiness following vaccines/Minor aches) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: weight gain.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patients mention joint pain that patient relates to being a bit overweight. Patient had achiness following vaccines. Lower back pain. Patient States that she did not felt like humira was helping her with psoriatic arthritis. She had Temporary minor aches, headaches, fatigue following all vaccines.   the causality for humira (adalimumab) for the event(s) of surgery, fatigue after all covid vaccine, sore arm after covid vaccine booster dose, overweight, swollen ankles, flare, weight gain, depression, covid 19, headaches following all covid vaccines, lower back pain, achiness following vaccines, hair loss and joint pain in various areas was not provided. the reporter's causality for the event(s) of did not felt humira was helping to psoriatic arthritis with humira(adalimumab) was a reasonable possibility.  the other Regulatory Authority (abbvie's) opinion is that there is no reasonable possibility that the events of surgery, fatigue after all covid vaccine, sore arm after covid vaccine booster dose, overweight, swollen ankles, flare, weight gain, depression, covid 19, headaches following all covid vaccines, did not felt humira was helping to psoriatic arthritis, lower back pain, achiness following vaccines and joint pain in various areas are related to humira(adalimumab) and the event of hair loss is not assessable.   Action taken with all the events with respect to Both the Co-suspect drugs were reported as Unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment details 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.  CC: This spontaneous case concerns a 50-year-old, female patient with concurrent conditions of psoriatic arthritis and rheumatoid arthritis treated with adalimumab and with a concomitant medication of methotrexate, who experienced an unexpected, medically significant Psoriatic arthritis (PsA) flare in association with a 2nd dose of mRNA-1273 vaccine. Exact onset latency of the event PsA flare relative to vaccination cannot be determined with an unknown event's onset date. Event PsA flare may have presented as swollen ankles and joint pain in various areas. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 28 days apart, followed by a booster dose. Event COVID-19 occurred 67 days after the booster vaccination with mRNA-1273 vaccine; thus, vaccination failure was noted in this case. On unknown dates, she had temporary minor aches, headaches, and fatigue following all vaccines. Patient's underlying conditions and treatment with adalimumab as well as methotrexate remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.   This case was linked to MOD-2022-623020 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow up received and included event information, reporter opinion of causality, suspect drug information and narrative description. the events of swollen ankles and achiness following vaccines" were added. On 06-May-2022: Follow up received and included event information, reporter opinion of causality, suspect drug information and narrative description. the events of overweight and hair loss were added. On 06-Jul-2022: Followup received and included received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures, and narrative description. the events of surgery, flare, weight gain, depression and joint pain in various areas were added.; Sender's Comments: This spontaneous case concerns a 50-year-old, female patient with concurrent conditions of psoriatic arthritis and rheumatoid arthritis treated with adalimumab and with a concomitant medication of methotrexate, who experienced an unexpected, medically significant Psoriatic arthritis (PsA) flare in association with a 2nd dose of mRNA-1273 vaccine. Exact onset latency of the event PsA flare relative to vaccination cannot be determined with an unknown event's onset date. Event PsA flare may have presented as swollen ankles and joint pain in various areas. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 28 days apart, followed by a booster dose. Event COVID-19 occurred 67 days after the booster vaccination with mRNA-1273 vaccine; thus, vaccination failure was noted in this case. On unknown dates, she had temporary minor aches, headaches, and fatigue following all vaccines. Patient's underlying conditions and treatment with adalimumab as well as methotrexate remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.