Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: did not feel well; felt bad; arm was really sore; swollen arm; red arm; achy; shortness of breath; fluctuating heart rate; woke up with heart rate of 165; hurt all the way across the shoulder to other arm.; she felt sort of tired; left side near the collarbone there is a knot which sort of wiggles sometimes It is size of a small marble, which is soft knot was red; bones were aching and hurting; left leg was soring/ left leg was aching; swelling in left leg; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well), FEELING ABNORMAL (felt bad), VACCINATION SITE PAIN (arm was really sore), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (red arm) in a 71-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.     Concurrent medical conditions included Blood pressure abnormal (Blood pressure), Diabetes and Arthritis. Concomitant products included MELOXICAM for Arthritis, METOPROLOL for Blood pressure abnormal, METFORMIN for Diabetes, CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), VITAMIN D NOS and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (she felt sort of tired). On 11-Nov-2021, the patient experienced MALAISE (did not feel well), FEELING ABNORMAL (felt bad), VACCINATION SITE PAIN (arm was really sore), VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red arm), MYALGIA (achy), DYSPNOEA (shortness of breath), HEART RATE IRREGULAR (fluctuating heart rate), HEART RATE INCREASED (woke up with heart rate of 165) and ARTHRALGIA (hurt all the way across the shoulder to other arm.). In November 2021, the patient experienced SKIN MASS (left side near the collarbone there is a knot which sort of wiggles sometimes It is size of a small marble, which is soft knot was red), BONE PAIN (bones were aching and hurting), PAIN IN EXTREMITY (left leg was soring/ left leg was aching) and PERIPHERAL SWELLING (swelling in left leg). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 11-Nov-2021, DYSPNOEA (shortness of breath), HEART RATE IRREGULAR (fluctuating heart rate) and HEART RATE INCREASED (woke up with heart rate of 165) had resolved. At the time of the report, MALAISE (did not feel well), FEELING ABNORMAL (felt bad), VACCINATION SITE PAIN (arm was really sore), VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red arm), MYALGIA (achy), SKIN MASS (left side near the collarbone there is a knot which sort of wiggles sometimes It is size of a small marble, which is soft knot was red), BONE PAIN (bones were aching and hurting), PAIN IN EXTREMITY (left leg was soring/ left leg was aching), PERIPHERAL SWELLING (swelling in left leg), ARTHRALGIA (hurt all the way across the shoulder to other arm.) and FATIGUE (she felt sort of tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, Heart rate: 165 (High) 165 and fluctuating (abnormal) fluctuating.         Unknown medication was used for blood pressure is concomitant medication reported  This is a spontaneous case concerning a 71-year-old, female patient with medical history of diabetes, arthritis and blood pressure disorder,  who experienced the unexpected non serious  serious events of malaise, feeling abnormal, leg pain and swelling, herat rate increased and irregularity, bone pain, dyspnoea and skin mass; and the expected non serious events of vaccination site pain, vaccination site swelling, vaccination site erythema, fatigue, arthralgia and myalgia . The event occurred after the third dose of mRNA 1273 vaccine. The rechallenge is not applicable. The medical history of diabetes and arthritis .   The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old, female patient with medical history of diabetes, arthritis and blood pressure disorder,  who experienced the unexpected non serious  serious events of malaise, feeling abnormal, leg pain and swelling, herat rate increased and irregularity, bone pain, dyspnoea and skin mass; and the expected non serious events of vaccination site pain, vaccination site swelling, vaccination site erythema, fatigue, arthralgia and myalgia . The event occurred after the third dose of mRNA 1273 vaccine. The rechallenge is not applicable. The medical history of diabetes and arthritis .   The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.