Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Peripheral swelling
Clinical narrative: They had to drain fluids out of her legs; Thought she was going to be gone from that; Legs were swelling; Shortness of breath , she could not breathe; Anxiety; Shoulder hurts; Stress test almost took her out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OEDEMA PERIPHERAL (They had to drain fluids out of her legs), PERIPHERAL SWELLING (Legs were swelling), DYSPNOEA (Shortness of breath , she could not breathe) and FEELING ABNORMAL (Thought she was going to be gone from that) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PERIPHERAL SWELLING (Legs were swelling) (seriousness criterion hospitalization prolonged) and DYSPNOEA (Shortness of breath , she could not breathe) (seriousness criterion hospitalization prolonged). On 17-May-2021, the patient experienced FEELING ABNORMAL (Thought she was going to be gone from that) (seriousness criterion hospitalization prolonged), ANXIETY (Anxiety), ARTHRALGIA (Shoulder hurts) and FATIGUE (Stress test almost took her out). On an unknown date, the patient experienced OEDEMA PERIPHERAL (They had to drain fluids out of her legs) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 17-May-2021 to 26-May-2021 due to DYSPNOEA, FEELING ABNORMAL, OEDEMA PERIPHERAL and PERIPHERAL SWELLING. At the time of the report, OEDEMA PERIPHERAL (They had to drain fluids out of her legs), PERIPHERAL SWELLING (Legs were swelling), DYSPNOEA (Shortness of breath , she could not breathe), FEELING ABNORMAL (Thought she was going to be gone from that), ANXIETY (Anxiety), ARTHRALGIA (Shoulder hurts) and FATIGUE (Stress test almost took her out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication provided was Blood pressure medication. After the Moderna vaccine she had shortness of breath, legs were swelling, she could not breathe. She was working until she no longer was able to breathe. She then was admitted to the ICU on 17-May-2021 and stayed in the hospital for 2 weeks and was discharged 26-May-2021. She reported that she was put on 15 different medications. She was put on heart medications, breathing treatments and pumps, muscle relaxants because her shoulder hurts, they had to drain fluids out of her legs and she also had a heart stress test which almost took her out, and she thought she was going to be gone from that. She now also was put on anxiety medication for her anxiety. She reports that she cannot work.  Treatment included amlodipine, furosemide, Aldactone, carvedilol, Ambien, methocarbamol, Prednisone, Anxiety medication, clonidine, , APAP 500mg, Zestril, Albuterol Proair HFA, Symbicort), ans she had fluid drained out of her legs.  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.; Sender'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.