Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Gait disturbance, Hepatic enzyme, Hepatic enzyme increased, Memory impairment
Clinical narrative: Covid-19; Elevated liver enzymes; Psoriatic arthritis aggravated; Drug effect Decreased; Memory impairment; Walking difficulty; Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), HEPATIC ENZYME INCREASED (Elevated liver enzymes) and PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) in an adult 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 product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-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) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19) (seriousness criteria hospitalization and medically significant), HEPATIC ENZYME INCREASED (Elevated liver enzymes) (seriousness criteria hospitalization and medically significant), PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) (seriousness criterion medically significant), THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect Decreased), MEMORY IMPAIRMENT (Memory impairment), GAIT DISTURBANCE (Walking difficulty) and RASH PRURITIC (Itchy rash). The patient was treated with METHOTREXATE for Difficulty in walking, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) and MEMORY IMPAIRMENT (Memory impairment) outcome was unknown, HEPATIC ENZYME INCREASED (Elevated liver enzymes) and GAIT DISTURBANCE (Walking difficulty) had resolved and PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated), THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect Decreased) and RASH PRURITIC (Itchy rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  On unknown date patient experienced problem in walking and was prescribed methotrexate to clear up walking problems, she got COVID-19 and was in intensive care unit for 10 days and her liver enzyme were extremely high after taking Methotrexate so went off Methotrexate. Pain in back after she stop Methotrexate. Humira seemed to be not as effective after stopping Methotrexate and rash was itchy but not as much with Humira. After patient had covid-19 vaccine, memory seemed to be not as good as it was before, psoriatic arthritis flares. Her pain was deep within back and could take longer than usual to work.  It was unknown if patient was enrolled in clinical trial.  Company Comment: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the unexpected serious events of Psoriatic Arthropathy (Medically Significant), Hepatic Enzyme Increased (Medically Significant and Hospitalization) and adverse event of special interest, COVID-19 (Medically Significant and Hospitalization). The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. As reported, patient was treated with Methotrexate for walking difficulties. Patient had COVID-19 on an unknown date and was admitted at the ICU, noted with elevated liver enzymes Methotrexate was stopped and was replaced with co-suspect, non-company product Adalimumab (Humira). The treatment was not as effective according to the physician as patient also suffered from back pain and itchy rash. It was also noted patient had poor memory. No further clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the unexpected serious events of Psoriatic Arthropathy (Medically Significant), Hepatic Enzyme Increased (Medically Significant and Hospitalization) and adverse event of special interest, COVID-19 (Medically Significant and Hospitalization). The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. As reported, patient was treated with Methotrexate for walking difficulties. Patient had COVID-19 on an unknown date and was admitted at the ICU, noted with elevated liver enzymes Methotrexate was stopped and was replaced with co-suspect, non-company product Adalimumab (Humira). The treatment was not as effective according to the physician as patient also suffered from back pain and itchy rash. It was also noted patient had poor memory. No further clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.