Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Condition aggravated, Fibromyalgia, Headache, Illness
Clinical narrative: She was in bed for 9 days; Fibromyalgia muscle aches and pain were to a point where she could not stand it; She was so sick; Condition aggravated; She had a headache for 9 days; She had a fever for 9 days; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (She was in bed for 9 days), FIBROMYALGIA (Fibromyalgia muscle aches and pain were to a point where she could not stand it), ILLNESS (She was so sick), CONDITION AGGRAVATED (Condition aggravated) and HEADACHE (She had a headache for 9 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia (Fibromyalgia at baseline). Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CEFALEXIN (CEFALIN [CEFALEXIN]), SALBUTAMOL (VENTOLINE [SALBUTAMOL]), LOSARTAN, VENLAFAXINE, PANTOPRAZOLE, HYDROCODONE, VITAMIN D [VITAMIN D NOS], IRON and PRAVASTATIN for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced BEDRIDDEN (She was in bed for 9 days), FIBROMYALGIA (Fibromyalgia muscle aches and pain were to a point where she could not stand it), ILLNESS (She was so sick), HEADACHE (She had a headache for 9 days) and PYREXIA (She had a fever for 9 days). 15-Apr-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated). On 24-Apr-2021, BEDRIDDEN (She was in bed for 9 days), HEADACHE (She had a headache for 9 days) and PYREXIA (She had a fever for 9 days) had resolved. At the time of the report, FIBROMYALGIA (Fibromyalgia muscle aches and pain were to a point where she could not stand it), ILLNESS (She was so sick) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.            Concomitant medications also included Advair diskus. No treatment details were reported. Patient does not have a history of COVID-19 infection. Patient does not have a history of myocarditis/pericarditis. Second dose Lot number Lot 039C21A After the second vaccine, the patient was so sick and was in bed for 9 days. The patient had fibromyalgia at baseline. The patient had fibromyalgia muscle aches and pain were to a point where the patient could not stand it, patient had a headache and fever for 9 days.  On an unknown date, the patient had EKG, then a stress test, waiting for a results.  This case concerns a 64 year-old female patient with a history of fibromyalgia who experienced the unexpected adverse event of special interest: fibromyalgia. The event occurred approximately 1 day after the second dose of Moderna COVID-19 vaccine. The rechallenge was positive as muscle pain returned after a third dose as booster. The medical history of fibromyalgia remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-371737, MOD-2021-371801 (Patient Link).; Sender's Comments: This case concerns a 64 year-old female patient with a history of fibromyalgia who experienced the unexpected adverse event of special interest: fibromyalgia. The event occurred approximately 1 day after the second dose of Moderna COVID-19 vaccine. The rechallenge was positive as muscle pain returned after a third dose as booster. The medical history of fibromyalgia remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.