Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Balance disorder, Fall, Fatigue, Feeling hot
Clinical narrative: fell into her bed because of the fatigue; her balance is off anyway because she has a balance issues; has severe arthritis so her joints hurt anyway buit this was something else; felt warm; fatigue; headache; muscle pain all over her body; nausea a couple of times; vomit; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell into her bed because of the fatigue), BALANCE DISORDER (her balance is off anyway because she has a balance issues), ARTHRITIS (has severe arthritis so her joints hurt anyway buit this was something else), FEELING HOT (felt warm) and FATIGUE (fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 001B21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (Severe). Concomitant products included DULOXETINE for Muscle cramps, PANTOPRAZOL [PANTOPRAZOLE] for Ulcer bleeding, LOSARTAN, METOPROLOL, METHOTREXATE, FOLIC ACID, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM, COLECALCIFEROL (CALCIUM WITH D3), ATORVASTATIN, MONTELUKAST and GLUCOSAMINE for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced FALL (fell into her bed because of the fatigue), BALANCE DISORDER (her balance is off anyway because she has a balance issues), ARTHRITIS (has severe arthritis so her joints hurt anyway buit this was something else), FEELING HOT (felt warm), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain all over her body), NAUSEA (nausea a couple of times) and VOMITING (vomit). In November 2021, FEELING HOT (felt warm), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain all over her body), NAUSEA (nausea a couple of times) and VOMITING (vomit) had resolved. At the time of the report, FALL (fell into her bed because of the fatigue), BALANCE DISORDER (her balance is off anyway because she has a balance issues) and ARTHRITIS (has severe arthritis so her joints hurt anyway buit this was something else) outcome was unknown.            No treatment medications were reported. Other Concomitant medications include water pill and B complex. Caller did not had any side effects with the first two doses.  This case concerns a 75-year-old, female patient with medical history of arthritis, who experienced the unexpected non serious events of arthritis, feeling hot, balance disorder and fall and expected events of fatigue, headache, myalgia, arthralgia, nausea and vomiting.The events occurred in after the third dose of mRNA-1273. The patient experienced mentioned symptoms which lasted for about a day. As reported,  the patient fell into her bed because of the fatigue, her balance is off anyway because she has a balance issue, has severe arthritis so her joints hurt anyway but this was something else. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The medical history of arthritis and concomitant use of duloxetine and methotrexate remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 75-year-old, female patient with medical history of arthritis, who experienced the unexpected non serious events of arthritis, feeling hot, balance disorder and fall and expected events of fatigue, headache, myalgia, arthralgia, nausea and vomiting.The events occurred in after the third dose of mRNA-1273. The patient experienced mentioned symptoms which lasted for about a day. As reported,  the patient fell into her bed because of the fatigue, her balance is off anyway because she has a balance issue, has severe arthritis so her joints hurt anyway but this was something else. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The medical history of arthritis and concomitant use of duloxetine and methotrexate remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.