Age: 78.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Vomiting
Clinical narrative: Septal infarction/Patient was very sick/Patient didn't feel well/ Horrible chest pains/ Sweating all over / Very nauseated/ Felt dizzy/ Patient felt terrible / She went in bed; Patient couldn´t even move to the phone to ask for help; Vomited; Patient did not have much memory of those days; Patient had tachycardia, had tachycardia a couple of times; Patient blood pressure went too low; Patient felt super, super weak, not having energy at all; Patient was walking with a walker; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Septal infarction/Patient was very sick/Patient didn't feel well/ Horrible chest pains/ Sweating all over / Very nauseated/ Felt dizzy/ Patient felt terrible / She went in bed), MOBILITY DECREASED (Patient couldn´t even move to the phone to ask for help), VOMITING (Vomited), MEMORY IMPAIRMENT (Patient did not have much memory of those days), TACHYCARDIA (Patient had tachycardia, had tachycardia a couple of times), HYPOTENSION (Patient blood pressure went too low), ASTHENIA (Patient felt super, super weak, not having energy at all) and GAIT DISTURBANCE (Patient was walking with a walker) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71Y6B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Concurrent medical conditions included Drug hypersensitivity (Codeine allergy), Blood pressure abnormal and Diabetes. Concomitant products included LISINOPRIL for Blood pressure abnormal, METFORMIN for Diabetes, GABAPENTIN for an unknown indication.    On 27-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Septal infarction/Patient was very sick/Patient didn't feel well/ Horrible chest pains/ Sweating all over / Very nauseated/ Felt dizzy/ Patient felt terrible / She went in bed) (seriousness criteria hospitalization and medically significant), MOBILITY DECREASED (Patient couldn´t even move to the phone to ask for help) (seriousness criterion hospitalization), VOMITING (Vomited) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (Patient did not have much memory of those days) (seriousness criterion hospitalization), TACHYCARDIA (Patient had tachycardia, had tachycardia a couple of times) (seriousness criterion hospitalization), HYPOTENSION (Patient blood pressure went too low) (seriousness criterion hospitalization), ASTHENIA (Patient felt super, super weak, not having energy at all) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Patient was walking with a walker) (seriousness criterion hospitalization). The patient was treated with Surgery (Cardiac catheterization with IV heparin) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Septal infarction/Patient was very sick/Patient didn't feel well/ Horrible chest pains/ Sweating all over / Very nauseated/ Felt dizzy/ Patient felt terrible / She went in bed), MOBILITY DECREASED (Patient couldn´t even move to the phone to ask for help), VOMITING (Vomited), MEMORY IMPAIRMENT (Patient did not have much memory of those days), TACHYCARDIA (Patient had tachycardia, had tachycardia a couple of times), HYPOTENSION (Patient blood pressure went too low), ASTHENIA (Patient felt super, super weak, not having energy at all) and GAIT DISTURBANCE (Patient was walking with a walker) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low. On an unknown date, Electrocardiogram: Septal infarction with T-Wave abnormality. Abnormal ECG..         Patient did not have medical history related to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient did not have other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient underwent cardiac catheterization with IV heparin as a routine, and she did not needed stents. Patient did not experienced similar event in the past.  Company comment: This spontaneous case reported by a patient concerns a 78-year-old female patient, with relevant medical history of diabetes mellitus, hypertension and COVID 19, who experienced the serious (caused hospitalization) unexpected events of Myocardial infarction, Mobility decreased, Vomiting, Memory impairment, Tachycardia, Hypotension, Asthenia, and Gait disturbance which occurred unknown days after fourth dose of mRNA-1273.222 bivalent vaccine administration. Unknown days after vaccination, the patient felt unwell, sick, and experienced nausea, chest pain, sweating, dizziness, vomiting and tachycardia. She was admitted to a hospital. Electrocardiogram was performed and she was diagnosed with septal infarction with T-wave abnormality. Patient underwent cardiac catheterization with IV heparin for treatment. After discharge, she experienced tachycardia, hypotension and needed walker for walking. Mentioned medical history of diabetes mellitus, hypertension and COVID 19 remain confounding for the event myocardial infarction. The benefit -risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to MOD-2022-659173, MOD-2022-659178 (Patient Link).; Sender's Comments: This spontaneous case reported by a patient concerns a 78-year-old female patient, with relevant medical history of diabetes mellitus, hypertension and COVID 19, who experienced the serious (caused hospitalization) unexpected events of Myocardial infarction, Mobility decreased, Vomiting, Memory impairment, Tachycardia, Hypotension, Asthenia, and Gait disturbance which occurred unknown days after fourth dose of mRNA-1273.222 bivalent vaccine administration. Unknown days after vaccination, the patient felt unwell, sick, and experienced nausea, chest pain, sweating, dizziness, vomiting and tachycardia. She was admitted to a hospital. Electrocardiogram was performed and she was diagnosed with septal infarction with T-wave abnormality. Patient underwent cardiac catheterization with IV heparin for treatment. After discharge, she experienced tachycardia, hypotension and needed walker for walking. Mentioned medical history of diabetes mellitus, hypertension and COVID 19 remain confounding for the event myocardial infarction. The benefit -risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.