Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: inflammation; HEADACHE/Daily headache; RED AT INJECTION SITE; SORENESS IN ARM; SWELLING ON ARM IS NOW THE SIZE OF A GRAPEFRUIT; SWOLLEN ARM THE SIZE OR A GOFL BALL; HIVES ON ARM; COULDN'T GET OFF THE COUCH; blood pressure 160/140; muscular pain in legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure 160/140), PERIPHERAL SWELLING (SWOLLEN ARM THE SIZE OR A GOFL BALL), URTICARIA (HIVES ON ARM), HYPOKINESIA (COULDN'T GET OFF THE COUCH) and INFLAMMATION (inflammation) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20N and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Chronic heart failure in 2004, Diabetes in 2008 and Hyperlipidemia in 2008. Concurrent medical conditions included Blood pressure since 2008, Acute otitis media with effusion since 1959 and Drug allergy (PCN, Sulfa, beta blockers, ARBs). Concomitant products included CANDESARTAN for Blood pressure, LEVOFLOXACIN and CLINDAMYCIN for Ear infection, CARVEDILOL, LEVOTHYROXINE, METFORMIN, PANTOPRAZOLE, FOLIC ACID, EZETIMIBE, SIMVASTATIN (EZETIMIBE & SIMVASTATIN), POTASSIUM CHLORIDE (KLOR-CON), VITAMIN B12 (CYANOCOBALAMIN AND ANALOGUES), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and VITAMIN D3 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (SWOLLEN ARM THE SIZE OR A GOFL BALL), URTICARIA (HIVES ON ARM), HYPOKINESIA (COULDN'T GET OFF THE COUCH), HEADACHE (HEADACHE/Daily headache), VACCINATION SITE ERYTHEMA (RED AT INJECTION SITE), VACCINATION SITE PAIN (SORENESS IN ARM) and VACCINATION SITE SWELLING (SWELLING ON ARM IS NOW THE SIZE OF A GRAPEFRUIT). In March 2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure 160/140) and MYALGIA (muscular pain in legs). On an unknown date, the patient experienced INFLAMMATION (inflammation). The patient was treated with CANDESARTAN (oral) for Blood pressure, at an unspecified dose and frequency. In April 2021, BLOOD PRESSURE INCREASED (blood pressure 160/140) had resolved. At the time of the report, PERIPHERAL SWELLING (SWOLLEN ARM THE SIZE OR A GOFL BALL), URTICARIA (HIVES ON ARM), HYPOKINESIA (COULDN'T GET OFF THE COUCH), INFLAMMATION (inflammation), HEADACHE (HEADACHE/Daily headache), VACCINATION SITE ERYTHEMA (RED AT INJECTION SITE), VACCINATION SITE PAIN (SORENESS IN ARM) and VACCINATION SITE SWELLING (SWELLING ON ARM IS NOW THE SIZE OF A GRAPEFRUIT) outcome was unknown and MYALGIA (muscular pain in legs) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: 160/140 (High) 160/140. In March 2021, C-reactive protein: 60 (High) 60.         Patient went to Cardiologist for blood pressure.    This case was linked to US-MODERNATX, INC.-MOD-2021-126158 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporter and Patient information updated, Medical history, allergies, concomitant drugs , new events, lab test, treatment information and vaccine information updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-126158:First dose