Reporte zur Charge 9399U1

Symptomtext

calcification in her right ankle that needed surgery; tightness in her right ankle but it was barely mild at the beginning; tightness in her left hip but it was barely mild at the beginning; 2 weeks of bleeding heavy, but it was not her period; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (2 weeks of bleeding heavy, but it was not her period), JOINT STIFFNESS (tightness in her right ankle but it was barely mild at the beginning), MUSCLE TIGHTNESS (tightness in her left hip but it was barely mild at the beginning) and CALCIFICATION OF MUSCLE (calcification in her right ankle that needed surgery) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 9399U1) for COVID-19 vaccination. The patient's past medical history included Surgery on 13-Jun-2022. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) and PARACETAMOL (TYLENOL) for Pain and Inflammation. On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Oct-2021, the patient experienced VAGINAL HAEMORRHAGE (2 weeks of bleeding heavy, but it was not her period). On 30-Oct-2021, the patient experienced JOINT STIFFNESS (tightness in her right ankle but it was barely mild at the beginning) and MUSCLE TIGHTNESS (tightness in her left hip but it was barely mild at the beginning). On 13-Jun-2022, the patient experienced CALCIFICATION OF MUSCLE (calcification in her right ankle that needed surgery). On 30-Oct-2021, VAGINAL HAEMORRHAGE (2 weeks of bleeding heavy, but it was not her period) had resolved. At the time of the report, JOINT STIFFNESS (tightness in her right ankle but it was barely mild at the beginning) and MUSCLE TIGHTNESS (tightness in her left hip but it was barely mild at the beginning) had not resolved and CALCIFICATION OF MUSCLE (calcification in her right ankle that needed surgery) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: a calcification in her ankle. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient did not have Allergies with medications, food and other products. Patient never had COVID + test or diagnosis. Patient did not mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient did not receive other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The AE cause patient to seek medical care visited orthopedic doctor, surgeon. The patient did not experience a similar event in the past. Treatment reported as Surgery, physical therapy, and pain medicine and anti-inflammatory like Advil or Tylenol. This case was linked to MOD-2021-339090 (Patient Link).