Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac stress test, Chest discomfort, Decreased appetite, Dizziness
Clinical narrative: patient passed out; racing heart; weakness; patients health deteriorated from that point on. Patient "mostly laid around the house"; lost a lot of weight; loss of appetite; she had a lot of chest pressure/Felt like an elephant was sitting on my chest; dizziness; nausea; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (patient passed out) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2022, the patient experienced LOSS OF CONSCIOUSNESS (patient passed out) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PALPITATIONS (racing heart), ASTHENIA (weakness), GENERAL PHYSICAL HEALTH DETERIORATION (patients health deteriorated from that point on. Patient "mostly laid around the house"), WEIGHT DECREASED (lost a lot of weight), DECREASED APPETITE (loss of appetite), CHEST DISCOMFORT (she had a lot of chest pressure/Felt like an elephant was sitting on my chest), DIZZINESS (dizziness) and NAUSEA (nausea). The patient was treated with NITROGLYCERIN at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (patient passed out), PALPITATIONS (racing heart), ASTHENIA (weakness), GENERAL PHYSICAL HEALTH DETERIORATION (patients health deteriorated from that point on. Patient "mostly laid around the house"), WEIGHT DECREASED (lost a lot of weight), DECREASED APPETITE (loss of appetite), CHEST DISCOMFORT (she had a lot of chest pressure/Felt like an elephant was sitting on my chest), DIZZINESS (dizziness) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: The patient had a stress test which she said they told her she did poorly on.         It was reported that on 3-Jun-2022 the patient was passed out and her friend called for an ambulance, and she was taken to the hospital. The patient had an EKG, ECG, and CT scan; however, the results were not reported. The patient was not diagnosed with myocarditis and pericarditis. The patient does not have a history of myocarditis or pericarditis. The patient does not have a history of Covid-19 infection.  Company Comment: This spontaneous case concerns a 61-years-old female patient, with  medical history of Blood pressure high, Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE who experienced the unexpected seriousness criterion seriousness criteria hospitalization and medically significant event of loss of consciousness, the unexpected events of palpitations, asthenia, General physical health deterioration, weight decreased, decreased appetite, chest discomfort and other expected events in the context  of  3rd.  dose of mRNA-1273 vaccine.  As there were only 23 days between Moderna Primary Series vaccines, Inappropriate schedule of vaccine administration event was noted. The serious event occurred 7 months after the mentioned dose. The medical condition of blood pressure high is a confounder for palpitations event; the concomitant medication lisinopril is a contributor for loss of consciousness, chest discomfort and headache. The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to MOD-2022-664796, MOD-2022-664801, MOD-2022-664803 (Patient Link). Sender's Comments: Company Comment This spontaneous case concerns a 61-years-old female patient, with  medical history of Blood pressure high, Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE who experienced the unexpected seriousness criterion seriousness criteria hospitalization and medically significant event of loss of consciousness, the unexpected events of palpitations, asthenia, General physical health deterioration, weight decreased, decreased appetite, chest discomfort and other expected events in the context  of  3rd.  dose of mRNA-1273 vaccine.  As there were only 23 days between Moderna Primary Series vaccines, Inappropriate schedule of vaccine administration event was noted. The serious event occurred 7 months after the mentioned dose. The medical condition of blood pressure high is a confounder for palpitations event; the concomitant medication lisinopril is a contributor for loss of consciousness, chest discomfort and headache. The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.