Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Mental status changes, Product administration error, Skin discolouration, Vaccination site bruising
Clinical narrative: Patient feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising; The patient had a discoloration in the arm and back, and on the upper left shoulder blade; Feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising/ The arm became sore, later the patient was in extreme discomfort; Did not feel comfortable with the way the vaccine was administered/ Injection was not at a 90 degrees angle and no more that 80 degrees; The arm became sore, later the patient was in extreme discomfort/ It hurt to move the arm; Mental status has change; Sleep in their car in their driveway with no explanation, doing odd things; This spontaneous case was reported by a nurse and describes the occurrence of SKIN DISCOLORATION (The patient had a discoloration in the arm and back, and on the upper left shoulder blade), VACCINATION SITE DISCOMFORT (Feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising/ The arm became sore, later the patient was in extreme discomfort), MENTAL STATUS CHANGES (Mental status has change), ABNORMAL BEHAVIOR (sleep in their car in their driveway with no explanation, doing odd things) and VACCINATION SITE BRUISING (Patient feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MENTAL STATUS CHANGES (Mental status has change) and ABNORMAL BEHAVIOR (Sleep in their car in their driveway with no explanation, doing odd things). On 07-Jul-2021, the patient experienced VACCINATION SITE DISCOMFORT (Feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising/ The arm became sore, later the patient was in extreme discomfort), VACCINATION SITE PAIN (The arm became sore, later the patient was in extreme discomfort/ It hurt to move the arm) and PRODUCT ADMINISTRATION ERROR (Did not feel comfortable with the way the vaccine was administered/ Injection was not at a 90 degrees angle and no more that 80 degrees). On 08-Jul-2021, the patient experienced SKIN DISCOLORATION (The patient had a discoloration in the arm and back, and on the upper left shoulder blade). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Patient feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising). On 07-Jul-2021, PRODUCT ADMINISTRATION ERROR (Did not feel comfortable with the way the vaccine was administered/ Injection was not at a 90 degrees angle and no more that 80 degrees) had resolved. At the time of the report, SKIN DISCOLORATION (The patient had a discoloration in the arm and back, and on the upper left shoulder blade) had not resolved and VACCINATION SITE DISCOMFORT (Feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising/ The arm became sore, later the patient was in extreme discomfort), MENTAL STATUS CHANGES (Mental status has change), ABNORMAL BEHAVIOR (Sleep in their car in their driveway with no explanation, doing odd things), VACCINATION SITE BRUISING (Patient feels very heavy, they hurt in that area and it is like having an infection because it is thickening and bruising) and VACCINATION SITE PAIN (The arm became sore, later the patient was in extreme discomfort/ It hurt to move the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  On 07-Jul-2021, the patient did not felt comfortable with the way the vaccine was administered, the administrator was nervous and pinching the arm of the patient and the patient saw that the injection was not at a 90 degrees angle and no more that 80 degrees. After getting the shot, the arm became sore, later the patient was in extreme discomfort and it hurt to move the arm.   The next day, the patient had a discoloration in the arm and back, and on the upper left shoulder blade. It was getting worse and was much worse that the COVID arm. The patient felt very heavy, it hurt in that area like having an infection because it was thickening and bruising.  On an unknown date, a few days ago of reporting, reporter noticed that the patient's mental status had changed, the patient had been doing odd things and was found sleeping in the car in their driveway on three different occasions with no explanation.; Sender's Comments: This case concerns a 47 year old female with no reported medical history , who experienced the unexpected events of vaccination site discomfort, product administration issue, this was accomapanied by expected event of vaccination site pain .which all occurred on the same day after vaccination with the 1st dose of mRNA-1273 (Moderna) . The day after the vaccination with the 1st dose unexpected events of vaccination site bruising and skin discoloration was noted. On an unknown time of onset unexpected events of mental status changes, Abnormal behavior occurred after the 1st dose of the vaccine. The rechallenge is not applicable for this case. The benefit - risk relationship of mRNA-1273 (Moderna ) is not affected by this report.