Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PAIN (Body Aches) and FATIGUE (Fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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) 40 milligram. In 2021, the patient experienced PAIN (Body Aches) and FATIGUE (Fatigue). In December 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), PAIN (Body Aches) and FATIGUE (Fatigue) outcome was unknown. Concomitant drug was not reported. The patient received Humira (solution for injection in pre-filled pen) with the dosage citrate free (40 mg). It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's causality for the events of Covid vaccine issue, fatigue, Covid vaccine issue, body aches and Covid was not provided for Humira. No treatment medication were provided. Company Comment: This is a spontaneous case concerning a 45-year-old female patient, with a concurrent medical condition of Psoriatic arthritis for which non-company co-suspect drug Humira was given, who experienced the unexpected non-serious events of COVID-19 (AESI), Pain (body aches; general body pain), and Fatigue. Event COVID-19 occurred approximately 8 - 9 months after the primary series of mRNA-1273 vaccine, the 2nd dose administered unknown number of days after the 1st dose while events Pain and Fatigue occurred unknown number of days after vaccination with mRNA vaccine (dose number unknown). There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The patient's psoriatic arthritis and co-suspect drug Humira, both of which can cause body aches and fatigue, remain as confounders for said events. Also, they are both associated with a lowered immune system, thus making them predisposition risk factors for COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 45-year-old female patient, with a concurrent medical condition of Psoriatic arthritis for which non-company co-suspect drug Humira was given, who experienced the unexpected non-serious events of COVID-19 (AESI), Pain (body aches; general body pain), and Fatigue. Event COVID-19 occurred approximately 8 - 9 months after the primary series of mRNA-1273 vaccine, the 2nd dose administered unknown number of days after the 1st dose while events Pain and Fatigue occurred unknown number of days after vaccination with mRNA vaccine (dose number unknown). There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The patient's psoriatic arthritis and co-suspect drug Humira, both of which can cause body aches and fatigue, remain as confounders for said events. Also, they are both associated with a lowered immune system, thus making them predisposition risk factors for COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.