Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site indentation, SARS-CoV-2 test, Skin indentation, Vaccination site bruising, Vaccination site pain
Clinical narrative: indentations forming on her right arm where she had received her first dose, she says that there is no muscle in that area anymore as there is a big indentation there; indentations forming on her right arm where she had received her first dose, she says that there is no muscle in that area anymore as there is a big indentation there; bruising around the indentation; It hurts in that area and was getting worse; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDENTATION (indentations forming on her right arm where she had received her first dose, she says that there is no muscle in that area anymore as there is a big indentation there), SKIN INDENTATION (indentations forming on her right arm where she had received her first dose, she says that there is no muscle in that area anymore as there is a big indentation there) and VACCINATION SITE BRUISING (bruising around the indentation) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ETHINYLESTRADIOL, ETONOGESTREL (NUVARING) for Birth control.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INJECTION SITE INDENTATION (indentations forming on her right arm where she had received her first dose, she says that there is no muscle in that area anymore as there is a big indentation there) (seriousness criterion hospitalization), SKIN INDENTATION (indentations forming on her right arm where she had received her first dose, she says that there is no muscle in that area anymore as there is a big indentation there) (seriousness criterion hospitalization) and VACCINATION SITE BRUISING (bruising around the indentation) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION SITE PAIN (It hurts in that area and was getting worse). At the time of the report, INJECTION SITE INDENTATION (indentations forming on her right arm where she had received her first dose, she says that there is no muscle in that area anymore as there is a big indentation there), SKIN INDENTATION (indentations forming on her right arm where she had received her first dose, she says that there is no muscle in that area anymore as there is a big indentation there), VACCINATION SITE BRUISING (bruising around the indentation) and VACCINATION SITE PAIN (It hurts in that area and was getting worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: positive (Positive) COVID + test.         No treatment information was provided by the reporter.  No Allergies (medications, food and other products). No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Patient received her 2nd dose of the Moderna COVID-19 vaccine on 06MAR2021 in her left arm. After some time of receiving her 2nd dose, she started noticing indentations forming on her right arm where she had received her first dose. Patient brushed it off thinking it was nothing. However, it's been a year since she received her first dose and now there's bruising around the indentation. It hurts in that area and was getting worse. Patient said that there was no muscle in that area anymore as there was a big indentation there. Patient finally saw a doctor today for this issue as she had no idea what was going on. Consent given for safety follow-up with caller by phone. Consent denied for safety follow-up with HCP. Company comment: This spontaneous case concerns a 24-year-old female patient, with no relevant medical history, who experienced the serious (due to hospitalization) unexpected events of INJECTION SITE INDENTATION, SKIN INDENTATION and VACCINATION SITE BRUISING, some unspecified time after the second dose of mRNA-1273 vaccine in March 2021. According to the narrative of the source document, she experienced indentations forming on her right arm where she had had received her first dose.  About a year later, she consulted when she noticed that there was no more muscle in the affected area. No details of that consultation was reported. The benefit-risk relationship of the mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-538680.; Sender's Comments: This spontaneous case concerns a 24-year-old female patient, with no relevant medical history, who experienced the serious (due to hospitalization) unexpected events of INJECTION SITE INDENTATION, SKIN INDENTATION and VACCINATION SITE BRUISING, some unspecified time after the second dose of mRNA-1273 vaccine in March 2021. According to the narrative of the source document, she experienced indentations forming on her right arm where she had had received her first dose.  About a year later, she consulted when she noticed that there was no more muscle in the affected area. No details of that consultation was reported. The benefit-risk relationship of the mRNA-1273 is not affected by this report.