Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Fibromyalgia, Headache
Clinical narrative: HEADACHES; COVID-19; FIBROMYALGIA; UPSET STOMACH; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (FIBROMYALGIA), ABDOMINAL DISCOMFORT (UPSET STOMACH), HEADACHE (HEADACHES) and COVID-19 (COVID-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Peripheral neuropathy and Rheumatoid arthritis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In February 2021, the patient experienced FIBROMYALGIA (FIBROMYALGIA). In 2021, the patient experienced ABDOMINAL DISCOMFORT (UPSET STOMACH). On an unknown date, the patient experienced HEADACHE (HEADACHES) and COVID-19 (COVID-19). At the time of the report, FIBROMYALGIA (FIBROMYALGIA), ABDOMINAL DISCOMFORT (UPSET STOMACH), HEADACHE (HEADACHES) and COVID-19 (COVID-19) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient was taking her Rinvoq and then took her Vitamins an hour later and she was becoming nauseated. It did not happen if she took them all together. She took Rinvoq, Ibuprofen, nose spray. She said it did not happen if she chewed mint gum. Fall started in 2021. She also had fibromyalgia in Feb-2021, and other health issues. Her physician said it was one of the side effects. She had back and knee pain. Stated that she had a spinal cord stimulator implanted last month (Mar-2022), upset stomach with the first two vaccines. She had Headaches.  The reporter's causality for the event(s) of FIBROMYALGIA and UPSET STOMACH with RINVOQ was not provided.  No treatment information was provided.  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.  Company comment: This spontaneous case concerns a 63-year-old female patient, with relevant medical history of neuropathy peripheral, who experienced the unexpected non-serious AESIs Fibromyalgia and COVID-19 in the context of receiving a dose of mRNA-1273 vaccine. Patient received 4 doses of mRNA-1273 vaccine, wherein the 1st and 2nd doses given approximately 1 month apart, and 3rd dose received approximately 5 months later, and the 4th dose was received 6 months after that. Fibromyalgia occurred within the same month of 2nd dose vaccination, and COVID 19 occurred approximately 4 months after the 3rd dose. Patient experienced upset stomach with the first two doses and headache was also reported. Patient had fibromyalgia with symptoms of back pain and knee pain. Clinical course and treatment details were not reported. The medical history of neuropathy peripheral fibromyalgia and co-suspect Upadacitinib for rheumatoid arthritis could be confounders for fibromyalgia. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medication was reported.   This case was linked to MOD-2022-624415, MOD-2022-624635 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2022: Significant Live follow up information received, medical history, dosage information, events and narrative updated.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient, with relevant medical history of neuropathy peripheral, who experienced the unexpected non-serious AESIs Fibromyalgia and COVID-19 in the context of receiving a dose of mRNA-1273 vaccine. Patient received 4 doses of mRNA-1273 vaccine, wherein the 1st and 2nd doses given approximately 1 month apart, and 3rd dose received approximately 5 months later, and the 4th dose was received 6 months after that. Fibromyalgia occurred within the same month of 2nd dose vaccination, and COVID 19 occurred approximately 4 months after the 3rd dose. Patient experienced upset stomach with the first two doses and headache was also reported. Patient had fibromyalgia with symptoms of back pain and knee pain. Clinical course and treatment details were not reported. The medical history of neuropathy peripheral fibromyalgia and co-suspect Upadacitinib for rheumatoid arthritis could be confounders for fibromyalgia. The benefit-risk relationship of mRNA-1273 is not affected by this report.