Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac discomfort, Electrocardiogram, Hypertension, Loss of consciousness
Clinical narrative: She was passing out/she was in "poor condition"; They thought she was having a heart attack; Her blood pressure was up; Just a bad reaction to Moderna; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (She was passing out/she was in "poor condition") in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (She was passing out/she was in "poor condition") (seriousness criterion medically significant), CARDIAC DISCOMFORT (They thought she was having a heart attack), HYPERTENSION (Her blood pressure was up) and VACCINATION COMPLICATION (Just a bad reaction to Moderna). The patient was treated with OXYGEN on 04-Feb-2021 for Adverse event, at an unspecified dose and frequency. In February 2021, LOSS OF CONSCIOUSNESS (She was passing out/she was in "poor condition"), CARDIAC DISCOMFORT (They thought she was having a heart attack), HYPERTENSION (Her blood pressure was up) and VACCINATION COMPLICATION (Just a bad reaction to Moderna) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: high (High) BP was up. On 04-Feb-2021, Electrocardiogram: results not provided (Inconclusive) Results not provided.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that they told her that she should go to the hospital right away. They sent her in an ambulance to the hospital. During the ride, they gave her oxygen. She doesn't remember receiving any medications in the ambulance or ER  It was stated that she stayed in the ER until her signs corrected themselves.  She was indicated not to receive the second dose..  She was on medication for blood pressure issues.  Company Comment - This spontaneous case concerns a 84 year old female patient with no relevant medical history, who experienced the serious unexpected event of loss of consciousness. The event occurred on the same day after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable as this is the first dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 84 year old female patient with no relevant medical history, who experienced the serious unexpected event of loss of consciousness. The event occurred on the same day after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable as this is the first dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.