Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Fibromyalgia, Illness
Clinical narrative: COVID-19; Sickness; Fibromyalgia; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ILLNESS (Sickness) and FIBROMYALGIA (Fibromyalgia) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2022, 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) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19), ILLNESS (Sickness) and FIBROMYALGIA (Fibromyalgia). At the time of the report, COVID-19 (COVID-19) outcome was unknown, ILLNESS (Sickness) had resolved and FIBROMYALGIA (Fibromyalgia) had not resolved.            No concomitant  and treatment medication were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of COVID VACCINE SHOT THAT MADE REALLY SICK, NOT SURE IF MIGHT BE  ALREADY HAD COVID AND THAT WAS WHY unknown onset with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of FIBROMYALGIA and COVID VACCINE SHOT THAT MADE REALLY SICK, NOT SURE IF MIGHT BE ALREADY HAD COVID AND THAT WAS WHY unknown onset was not provided.  Company comment: This spontaneous case concerns a female patient of an unknown age, with concurrent medical history of ankylosing spondylitis, who experienced the unexpected non-serious adverse events of special interest COVID-19 and Fibromyalgia after receiving the 3rd dose of mRNA-1273 vaccine and co-suspect drug Adalimumab. The onset dates of events were not reported. Clinical course and treatment details were not reported. The outcome of fibromyalgia was reported as not resolved and COVID-19 unknown. Patient received mRNA-1273 vaccine as primary series at an interval of 31 days, and the 2nd dose was given approximately one year prior to the current mRNA-1273 vaccine. Medical history of ankylosing spondylitis could be considered as a risk factor for fibromyalgia and co-suspect Adalimumab as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with concurrent medical history of ankylosing spondylitis, who experienced the unexpected non-serious adverse events of special interest COVID-19 and Fibromyalgia after receiving the 3rd dose of mRNA-1273 vaccine and co-suspect drug Adalimumab. The onset dates of events were not reported. Clinical course and treatment details were not reported. The outcome of fibromyalgia was reported as not resolved and COVID-19 unknown. Patient received mRNA-1273 vaccine as primary series at an interval of 31 days, and the 2nd dose was given approximately one year prior to the current mRNA-1273 vaccine. Medical history of ankylosing spondylitis could be considered as a risk factor for fibromyalgia and co-suspect Adalimumab as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.