Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Contusion, Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: Superficial vein thrombosis; Bruising on the right lower ankle side of the legs, on the tender area; Bruising on the right lower ankle side of the legs, Bruising on the right lower ankle side of the legs, on the tender area / Painful at night; elevated D-dimer results; Fever of about 99-100 degrees Fahrenheit; Flu-like symptoms; This spontaneous case was reported by a nurse and describes the occurrence of THROMBOPHLEBITIS SUPERFICIAL (Superficial vein thrombosis), INFLUENZA LIKE ILLNESS (Flu-like symptoms), CONTUSION (Bruising on the right lower ankle side of the legs, on the tender area), ARTHRALGIA (Bruising on the right lower ankle side of the legs, Bruising on the right lower ankle side of the legs, on the tender area / Painful at night) and PYREXIA (Fever of about 99-100 degrees Fahrenheit) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028D21A, 003B214 and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESTRADIOL (ESTROGEN), PROGESTERONE, METOPROLOL and ROSUVASTATIN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever of about 99-100 degrees Fahrenheit). On 31-Aug-2021, the patient experienced THROMBOPHLEBITIS SUPERFICIAL (Superficial vein thrombosis), CONTUSION (Bruising on the right lower ankle side of the legs, on the tender area), ARTHRALGIA (Bruising on the right lower ankle side of the legs, Bruising on the right lower ankle side of the legs, on the tender area / Painful at night) and FIBRIN D DIMER INCREASED (elevated D-dimer results). The patient was treated with Manual therapy (Heat compress and compression stockings) for Thrombophlebitis superficial; Manual therapy (Heat compress and compression stockings) for Contusion and Manual therapy (Heat compress and compression stockings) for Arthralgia. At the time of the report, THROMBOPHLEBITIS SUPERFICIAL (Superficial vein thrombosis), INFLUENZA LIKE ILLNESS (Flu-like symptoms), CONTUSION (Bruising on the right lower ankle side of the legs, on the tender area), ARTHRALGIA (Bruising on the right lower ankle side of the legs, Bruising on the right lower ankle side of the legs, on the tender area / Painful at night), PYREXIA (Fever of about 99-100 degrees Fahrenheit) and FIBRIN D DIMER INCREASED (elevated D-dimer results) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: 99 to 100 (High) High. On 01-Sep-2021, Fibrin D dimer: elevated (High) Elevated. On 01-Sep-2021, Ultrasound scan: normal (normal) No clots were found.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.; 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.