Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Type IV hypersensitivity reaction, Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness at the area of the injection, the size of an egg; COVID arm; Dizzy spell; Fall; Brain bleed; Intermittent episodes of high blood pressure; Intermittent episodes of rapid heartbeat; Difficulty sleeping; Headaches; soreness at the site of the injection; Flushing in her face; Humming in the ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMORRHAGE (Brain bleed) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced FLUSHING (Flushing in her face). 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of the injection). On 27-Jan-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Intermittent episodes of high blood pressure), HEART RATE INCREASED (Intermittent episodes of rapid heartbeat), INSOMNIA (Difficulty sleeping) and HEADACHE (Headaches). On 29-Jan-2021, the patient experienced CEREBRAL HAEMORRHAGE (Brain bleed) (seriousness criterion medically significant), DIZZINESS (Dizzy spell) and FALL (Fall). On 02-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (COVID arm). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the area of the injection, the size of an egg). On an unknown date, the patient experienced TINNITUS (Humming in the ears). On 25-Jan-2021, FLUSHING (Flushing in her face) and VACCINATION SITE PAIN (soreness at the site of the injection) had resolved. On 10-Feb-2021, TYPE IV HYPERSENSITIVITY REACTION (COVID arm) had resolved. At the time of the report, CEREBRAL HAEMORRHAGE (Brain bleed), DIZZINESS (Dizzy spell), FALL (Fall) and VACCINATION SITE ERYTHEMA (Redness at the area of the injection, the size of an egg) outcome was unknown and BLOOD PRESSURE FLUCTUATION (Intermittent episodes of high blood pressure), HEART RATE INCREASED (Intermittent episodes of rapid heartbeat), TINNITUS (Humming in the ears), INSOMNIA (Difficulty sleeping) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Electrocardiogram: normal (normal) Normal. On 01-Feb-2021, Magnetic resonance imaging: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment included steroids.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: New events of blood pressure fluctuation, heart rate increased, headache, Covid arm, tinnitus, dizziness, fall, insomnia, and cerebral haemorrhage (serious) added; case upgraded to serious; Labs coded; treatment information added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.