Age: 63.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Arthritis, Fibromyalgia, Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia/ Her body hurt and she experienced this soreness for five days), ILLNESS (Took one Moderna COVID vaccine and made her sick) and ARTHRITIS (Joint inflammation/ Knee swelling) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication. The patient's past medical history included COVID-19 (Hospitalized for 4 days) in October 2021, Cold on 14-Dec-2021, Cough on 14-Dec-2021, Hoarseness on 14-Dec-2021 and Joint pain in 2021. Concurrent medical conditions included Rheumatoid arthritis. On 22-Sep-2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 04-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) at an unspecified dose. In 2022, the patient experienced ILLNESS (Took one Moderna COVID vaccine and made her sick). On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia/ Her body hurt and she experienced this soreness for five days) and ARTHRITIS (Joint inflammation/ Knee swelling). At the time of the report, FIBROMYALGIA (Fibromyalgia/ Her body hurt and she experienced this soreness for five days) and ARTHRITIS (Joint inflammation/ Knee swelling) had not resolved and ILLNESS (Took one Moderna COVID vaccine and made her sick) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication provided. Patient took one Moderna vaccine and made her sick. Body hurt and she experienced this soreness for 5 days. She thought this could be due to her fibromyalgia. Prior to Moderna vaccination in OCT2021, patient had COVID-19 and was hospitalized for 4 days. She had a cough, cold and voice was hoarse as of 14DEC2021 which continued, and her HCP thought it was from the COVID. An inhaler was prescribed then for the same. She lacks energy, she thought this could be due to her fibromyalgia. She had been experiencing inflammation, swelling and soreness, especially in her knees. After getting the Shingles vaccine, she experienced achiness in her joints and muscles, which she believed was due to the fibromyalgia. No treatment information mentioned. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporters' causality of events with Humira was no reasonable possibility. Company comment: This is a Spontaneous case concerning a 63 years old female patient, with concurrent medical condition of Rheumatoid arthritis, who experienced the unexpected non serious (medically significant) AESI event of fibromyalgia, arthritis, which occurred unspecified days after first dose of mRNA-1273 vaccine. At the time of reporting events are not recovered. Concurrent medical condition of Rheumatoid arthritis is confounding for the event arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a Spontaneous case concerning a 63 years old female patient, with concurrent medical condition of Rheumatoid arthritis, who experienced the unexpected non serious (medically significant) AESI event of fibromyalgia, arthritis, which occurred unspecified days after first dose of mRNA-1273 vaccine. At the time of reporting events are not recovered. Concurrent medical condition of Rheumatoid arthritis is confounding for the event arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.