Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Arthralgia, Magnetic resonance imaging, Rotator cuff syndrome, Skin hypopigmentation
Clinical narrative: severe anemia; white spots just on her arms and shoulders./skin hypopigmentation; lot of white cells in her  urine; lot of shoulder pain; has 3 tears in his rotator cuff; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAEMIA (severe anemia), SKIN HYPOPIGMENTATION (white spots just on her arms and shoulders./skin hypopigmentation) and WHITE BLOOD CELLS URINE POSITIVE (lot of white cells in her  urine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided by the reporter.  Concomitant products included VALSARTAN and AMLODIPINE BESILATE (AMLODIPINE [AMLODIPINE BESILATE]) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced ROTATOR CUFF SYNDROME (has 3 tears in his rotator cuff). On an unknown date, the patient experienced ANAEMIA (severe anemia) (seriousness criterion medically significant), SKIN HYPOPIGMENTATION (white spots just on her arms and shoulders./skin hypopigmentation) (seriousness criterion medically significant), WHITE BLOOD CELLS URINE POSITIVE (lot of white cells in her  urine) (seriousness criterion medically significant) and ARTHRALGIA (lot of shoulder pain). At the time of the report, ANAEMIA (severe anemia), SKIN HYPOPIGMENTATION (white spots just on her arms and shoulders./skin hypopigmentation), ROTATOR CUFF SYNDROME (has 3 tears in his rotator cuff) and ARTHRALGIA (lot of shoulder pain) outcome was unknown and WHITE BLOOD CELLS URINE POSITIVE (lot of white cells in her  urine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) 3 tears in rotator cuff. On an unknown date, X-ray: abnormal (abnormal) 3 tears in rotator cuff.         The patient noticed white spots just on her arms and shoulders after they came back form vacation. On 13-Apr-2021, she went to see her  primary care physician and they referred her to a dermatologist. On 29-Apr-2021, the dermatologist said that  white spots were due to skin hypopigmentation and told her not to worry about it. She also had lot of shoulder pain and her doctor ordered MRI and X-Ray. She had three tears in her rotator cuff, but thought it  was due  to her age. On  10-Jun-2021, her doctor told her that she had severe anemia and referred her to a hematologist-oncologist, and from 23-Jun-2021 onwards she received  three iron infusions (once a week). She also found  lot of white cells in her  urine and  that was still an ongoing issue. Her doctors had never been  able  to tell her that what has caused her anemia and white cells in urine. No treatment information was 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.; 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.