Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Hypertensive crisis, Vaccination site erythema, Vaccination site haemorrhage
Clinical narrative: high blood pressure (230/120); L arm of vaccination site a circle around the area red and blooded; blood pressure high and down, but she has never had the blood; L arm of vaccination site warm to touch; L arm of vaccination site swollen; L arm of vaccination site a circle around the area red and blooded; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE CRISIS (high blood pressure (230/120)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure fluctuation (Patient reported is common for her to have high and low blood pressure.).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSIVE CRISIS (high blood pressure (230/120)) (seriousness criterion medically significant), VACCINATION SITE HAEMORRHAGE (L arm of vaccination site a circle around the area red and blooded), BLOOD PRESSURE FLUCTUATION (blood pressure high and down, but she has never had the blood), VACCINATION SITE WARMTH (L arm of vaccination site warm to touch), VACCINATION SITE SWELLING (L arm of vaccination site swollen) and VACCINATION SITE ERYTHEMA (L arm of vaccination site a circle around the area red and blooded). At the time of the report, HYPERTENSIVE CRISIS (high blood pressure (230/120)), VACCINATION SITE HAEMORRHAGE (L arm of vaccination site a circle around the area red and blooded), BLOOD PRESSURE FLUCTUATION (blood pressure high and down, but she has never had the blood), VACCINATION SITE WARMTH (L arm of vaccination site warm to touch), VACCINATION SITE SWELLING (L arm of vaccination site swollen) and VACCINATION SITE ERYTHEMA (L arm of vaccination site a circle around the area red and blooded) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood pressure measurement: 230/120 (High) high. On 14-Apr-2021, Blood pressure measurement: 150/80 (High) down to 150/80.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported taking blood pressure medication. She also indicated that she takes other medications, but no names or indications were provided as patient has been taking them for many years and does not consider them related to the event. No additional treatment medication was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.