Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site haemorrhage, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Bleeding at the injection site; Injection site to the elbow consistently ranging from 101.8 F then below 5 inch it is 100.1F; Arm where received injection gotten red/red in the area of about 8-10 inches in length and maybe 4 inches in width; Arm was sore/Hurts; Arm was swollen from my shoulder to my elbow, under and on top of arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding at the injection site), VACCINATION SITE WARMTH (Injection site to the elbow consistently ranging from 101.8 F then below 5 inch it is 100.1F), VACCINATION SITE ERYTHEMA (Arm where received injection gotten red/red in the area of about 8-10 inches in length and maybe 4 inches in width), VACCINATION SITE PAIN (Arm was sore/Hurts) and VACCINATION SITE SWELLING (Arm was swollen from my shoulder to my elbow, under and on top of arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011020A and 012mzoa) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (under control) since 1995. Concomitant products included METFORMIN for Diabetes, BENAZEPRIL HYDROCHLORIDE (LOTENSIN [BENAZEPRIL HYDROCHLORIDE]), FENOFIBRATE, PRAVASTATIN and BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) for an unknown indication.   On 11-Jan-2021 at 3:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site to the elbow consistently ranging from 101.8 F then below 5 inch it is 100.1F), VACCINATION SITE ERYTHEMA (Arm where received injection gotten red/red in the area of about 8-10 inches in length and maybe 4 inches in width) and VACCINATION SITE PAIN (Arm was sore/Hurts). In January 2021, the patient experienced VACCINATION SITE SWELLING (Arm was swollen from my shoulder to my elbow, under and on top of arm). On 16-Jan-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding at the injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 05-Feb-2021, VACCINATION SITE HAEMORRHAGE (Bleeding at the injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site to the elbow consistently ranging from 101.8 F then below 5 inch it is 100.1F), VACCINATION SITE ERYTHEMA (Arm where received injection gotten red/red in the area of about 8-10 inches in length and maybe 4 inches in width), VACCINATION SITE PAIN (Arm was sore/Hurts) and VACCINATION SITE SWELLING (Arm was swollen from my shoulder to my elbow, under and on top of arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Follow up information was received on 25-JAN-2021. Patient demographics, new event Vaccination site swelling, batch number and treatment information were added On 14-Apr-2021: Follow up information was received on 14 APR 2021. Outcome of events were changed from Unknown to not recovered and Vaccination site haemorrhage was updated from Unknown to recovered . Concomitant information incudes Metformin, Lotensin, Fenofibrate, Pravastatin, Combigan were added. On 03-Jul-2021: Non-significant follow-up appended