Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Headache for 4 days; Tiredness for 4 days; Muscle painfor 4 days; fever; She was so sick; She was in bed for 9 days; Fibromyalgia muscle aches were to a point where she could not stand it/fibromyalgia pain were to a point where she could not stand it; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She was so sick), BEDRIDDEN (She was in bed for 9 days), FIBROMYALGIA (Fibromyalgia muscle aches were to a point where she could not stand it/fibromyalgia pain were to a point where she could not stand it), HEADACHE (Headache for 4 days) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399C4, 006B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CEFALEXIN (CEFALIN [CEFALEXIN]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SALBUTAMOL (VENTOLIN [SALBUTAMOL]), LOSARTAN, VENLAFAXINE, PANTOPRAZOLE, HYDROCODONE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), PRAVASTATIN and IRON 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) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced PYREXIA (fever). On 28-Oct-2021, the patient experienced HEADACHE (Headache for 4 days), FATIGUE (Tiredness for 4 days) and MYALGIA (Muscle painfor 4 days). On an unknown date, the patient experienced ILLNESS (She was so sick), BEDRIDDEN (She was in bed for 9 days) and FIBROMYALGIA (Fibromyalgia muscle aches were to a point where she could not stand it/fibromyalgia pain were to a point where she could not stand it). In October 2021, HEADACHE (Headache for 4 days), PYREXIA (fever), FATIGUE (Tiredness for 4 days) and MYALGIA (Muscle painfor 4 days) had resolved. At the time of the report, ILLNESS (She was so sick), BEDRIDDEN (She was in bed for 9 days) and FIBROMYALGIA (Fibromyalgia muscle aches were to a point where she could not stand it/fibromyalgia pain were to a point where she could not stand it) had resolved.            Patient received the vaccine in deltoid. After the second vaccine, she was so sick, she was in bed for 9 days, she had fibromyalgia at baseline. She states her fibromyalgia muscle aches and pain were to a point where she could not stand it, she had a headache for 9 days and had a fever for 9 days. She got the booster and states that she had the same side effects from the second dose for 4 days including tiredness, muscle pain and headache for 4 days. Patient was having an appointment on 22 Dec 2021. It was mentioned that patient several years ago had a heart stress test done but she could not remember what it was for or why.  Laboratory tests included cardiac lab values electrocardiogram, cardiac test, cardiac enzymes, then a stress test with unknown results. Treatment information was not provided.  Company comment: This case concerns a 64-year-old, female patient with a history of fibromyalgia, who experienced the unexpected non-serious AESI event of fibromyalgia . The event fibromyalgia occurred at an unknown date after the third dose of Moderna COVID-19 vaccine. The rechallenge was unknow for the event, although the event happened after the second dose of the vaccine also, there is no information about outcome of the event after the previous dose. 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-2021-371800, MOD-2021-371737 (Patient Link).; Sender's Comments: This case concerns a 64-year-old, female patient with a history of fibromyalgia, who experienced the unexpected non-serious AESI event of fibromyalgia . The event fibromyalgia occurred at an unknown date after the third dose of Moderna COVID-19 vaccine. The rechallenge was unknow for the event, although the event happened after the second dose of the vaccine also, there is no information about outcome of the event after the previous dose. The medical history of fibromyalgia remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.