Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Restlessness, Urticaria
Clinical narrative: ate very little; weak; heartrate 120-130 when waking up by apple watch when waking up it came down 82-84 to normal; skin hot; hand sweating; naughty hives; feet sweated profusely; shaky feeling inside; Restless; Slightest diarrhea; itchy skin; headache; injection site red; Very nauseous; fever; fever; sore arm at the injection site; A spontaneous report was received from a physician concerning a 50-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced very nauseous, fever, sore arm on injection site, chills, itchy skin, headache, injection site red, restless, slightest diarrhea, feet sweated profusely, shaky feeling inside, naughty hives, skin hot, hand sweating, ate very little, weak and heart rate 120-130 when waking up.  The patient's medical history was not provided. Concomitant medications reported included fluoxetine, clonazepam, colecalciferol and alprazolam.  On 23 Dec 2020, approximately 1-11 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 24 Dec 2020 at 11:30, the patient felt very nauseous, had a fever that never went 100 degrees, chills, and sore arm at the injection site.   On 26 Dec 2020, the patient denied nausea but still had chills, fever, itchy skin, headache, and her arm was still red.   On 27 Dec 2020, the patient woke up with nausea and a great fever but felt better when she sat up and after taking a shower.   On 28 Dec 2020,  she was restless and had slight diarrhea.   On 29 Dec 2020, the patient had nausea again, her feet sweat profusely, had a shaky feeling inside, and took Benadryl before going to bed.   On 31 Dec 2020, the injection site was red again and she had hives for which she applied cortisone cream.   On 01 Jan 2021, she was shaky, had hot skin, nausea, arm redness, hand and feet were sweating, she ate very little, and had a tiny headache.   On 02 Jan 2021, the patient had a low grade fever and was nauseous.  On 03 Jan 2021, she woke up feeling shaky, was nauseous, had sweaty hands and feet, was weak, had a heart rate of 120-130 when she woke up but returned to normal of 82-84. She reported the arm redness was completely gone and she took alprazolam for sleep.   On 04 Jan, the patient woke up shaky, sweaty and had an elevated heart beat but denied nausea.  Treatment for the event included Benadryl, paracetamol and cortisone cream.  Action taken with mRNA-1273 in response to the events is not applicable.  The events, very nauseous and injection site red, were considered resolved on 03 Jan 2021. The outcome of the events, fever, sore arm on injection site, chills, itchy skin, headache, restless, slightest diarrhea, feet sweated profusely, shaky feeling inside, naughty hives, skin hot, hand sweating, ate very little, weak and heartrate 120-130 when waking, up were unknown.  The reporter did not provide the causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.