Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Insomnia, Pain
Clinical narrative: Back pain after first shot; Pain in his chest and his back after first shot; Burning sensation on his chest and back after first shot, Burning and Pain is radiating to other area; Not sleeping well at nights; Burning and Pain is radiating to other area; Fell down from the pain after first shot; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in his chest and his back after first shot), BURNING SENSATION (Burning sensation on his chest and back after first shot, Burning and Pain is radiating to other area) and BACK PAIN (Back pain after first shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, LOSARTAN, AMLODIPINE, TAMSULOSIN, DULAGLUTIDE (TRULICITY), INSULIN GLARGINE (LANTUS) and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 10-Apr-2021, the patient experienced CHEST PAIN (Pain in his chest and his back after first shot) (seriousness criterion hospitalization) and BURNING SENSATION (Burning sensation on his chest and back after first shot, Burning and Pain is radiating to other area) (seriousness criterion hospitalization). In 2021, the patient experienced FALL (Fell down from the pain after first shot). On 20-Aug-2021, the patient experienced PAIN (Burning and Pain is radiating to other area). On an unknown date, the patient experienced BACK PAIN (Back pain after first shot) (seriousness criterion hospitalization) and INSOMNIA (Not sleeping well at nights). The patient was hospitalized from 18-Apr-2021 to 22-Apr-2021 due to BACK PAIN, BURNING SENSATION and CHEST PAIN. At the time of the report, CHEST PAIN (Pain in his chest and his back after first shot), BURNING SENSATION (Burning sensation on his chest and back after first shot, Burning and Pain is radiating to other area), BACK PAIN (Back pain after first shot), FALL (Fell down from the pain after first shot), INSOMNIA (Not sleeping well at nights) and PAIN (Burning and Pain is radiating to other area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: normal (normal) Normal. On an unknown date, Endoscopy: normal (normal) normal.         Treatment medication was not provided  Company comment: 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. Further information has been requested.; 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. Further information has been requested.