Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gout, Pain in extremity
Clinical narrative: felt strange; arthritis; pain in the arm; gout; extreme fatigue/ felt very, very tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt strange), ARTHRITIS (arthritis), PAIN IN EXTREMITY (pain in the arm), GOUT (gout) and FATIGUE (extreme fatigue/ felt very, very tired) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A, 003C21A, 035C21A and 066K21A) for COVID-19 prophylaxis.     Patient received unspecified antibiotics and steroid drugs.  The patient's past medical history included Foot surgery (surgeries in her feet or bones.) in 2017 and Bone operation (surgeries in her feet or bones.) in 2017. Concurrent medical conditions included Hypothyroidism.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt strange), ARTHRITIS (arthritis), PAIN IN EXTREMITY (pain in the arm), GOUT (gout) and FATIGUE (extreme fatigue/ felt very, very tired). At the time of the report, FEELING ABNORMAL (felt strange) outcome was unknown and ARTHRITIS (arthritis), PAIN IN EXTREMITY (pain in the arm), GOUT (gout) and FATIGUE (extreme fatigue/ felt very, very tired) had resolved.            It was Patient did not remember if she received any other vaccine in the 4 weeks prior to receiving the Moderna vaccines.  Concomitant product use was not provided by the reporter.  It was reported that after the first dose she had extreme fatigue, pain in the arm, felt very, very tired and felt strange. After second dose it wasn´t as bad. After third and fourth dose patient had GOUT or arthritis.  Treatment information was not provided.  It was reported that she was susceptible to had this because of past surgeries in her feet or bones back in 2017.  Company Comment: This is a spontaneous case concerning an adult female patient, with medical history of foot surgery, who experienced the non-serious unexpected, AESI event of Arthritis, which occurred on an unknown date after a dose of mRNA-1273 vaccine // after the mRNA-1273 vaccine, received as the third or fourth dose of COVID-19 vaccination schedule. Patient received 4 doses of mRNA-1273 vaccine. It was reported that after the first dose she had extreme fatigue, pain in the arm, felt very tired and felt strange. After second dose it wasn´t as bad. After third and fourth dose patient had GOUT or arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-738184 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738184:Same Patient Bi-valent Dose