Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid19 2/28/23, w/mild to moderate symptoms (slight cough, drainage - nasal and back of the throat, body aches, severe headache, lack of energy); Mild heart attack 1/1/2023 (says cardiologist); This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Mild heart attack 1/1/2023 (says cardiologist)) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Appendicitis and Pancreatitis (Pancreatitis (acute 2019)) in 2019. Concurrent medical conditions included ADHD. Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE), CLOPIDOGREL, METOPROLOL, ROSUVASTATIN, FENOFIBRATE, MYDAYIS and COLECALCIFEROL, MENAQUINONE (VITAMIN K2 + D3 [COLECALCIFEROL;MENAQUINONE]) for an unknown indication.    On 01-Oct-2022 at 1:00 PM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Jan-2023, the patient experienced MYOCARDIAL INFARCTION (Mild heart attack 1/1/2023 (says cardiologist)) (seriousness criterion medically significant). On 28-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Tested positive for Covid19 2/28/23, w/mild to moderate symptoms (slight cough, drainage - nasal and back of the throat, body aches, severe headache, lack of energy)). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 28-Feb-2023 to 05-Mar-2023 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION (Mild heart attack 1/1/2023 (says cardiologist)) outcome was unknown and COVID-19 (Tested positive for Covid19 2/28/23, w/mild to moderate symptoms (slight cough, drainage - nasal and back of the throat, body aches, severe headache, lack of energy)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2023, SARS-CoV-2 test: Positive. In March 2023, SARS-CoV-2 test: (Positive) day10 and another rapid test shows still Covid19 positive and asymptomatic.         Suspect vaccine batch number was reported. Patient had no major blockage for the age and no stent used, minor damage to lower lobe, insignificant for patient's age, as and if patient maintain healthy diet, exercise and medications. It was reported that patient took other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received COVID-19 vaccines: On 21-Jan-2021 at 09:00 am, first dose of Moderna vaccine on right arm with batch/lot number 032L20A. On 23-Feb-2021 at 04:00 pm, second dose of Moderna vaccine on left leg with batch/lot number D24M20A. On 09-Nov-2021 at 10:00 am, third dose of Moderna vaccine on right arm with batch/lot number 025D21A. On 18-Apr-2022 at 01:00 pm, fourth dose of Moderna vaccine on left arm with batch/lot number 033K212A. Patient first Paxlovid dose was on 28-Feb-2023 evening. After second dose next morning, patient was asymptomatic for the rest of the day. On day 3 the symptoms returned with a vengeance. All the above were more severe and patient was bedridden until patient finished the 5-day course on 05-Mar-2023. Since day7 patient have been asymptomatic and have no lethargy and on day-10 another rapid test shows that patient still have  Covid19 positive and asymptomatic. Patient wife, who contracted the virus three days prior to patient's first positive test also took Paxlovid. It has taken her longer to recover, today she tested negative and asymptomatic. Patient was familiar with aseptic technique and confident that patient's testing procedures met the guidelines required and a read says a rebound may be asymptomatic. Patient stopped taking all other medications to insure no contraindications.  Company Comment: This is a spontaneous case concerning a 67-year-old male patient with no relevant medical history, who experienced the serious (due to medically significant) unexpected, AESI event of Myocardial infarction, which occurred approximately 3 months after the fifth dose of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine (received other 4 doses of Moderna as previous COVID-19 vaccination schedule). It was reported that according to cardiologist, patient had a mild heart attack. He had no major blockage, and no stent was used. There was a minor damage to lower lobe, insignificant for patient's age according to reporter, if patient maintains healthy diet, exercise, and medications. Concomitant medication reported was acetylsalicylic acid, clopidogrel, metoprolol, rosuvastatin and fenofibrate. Additionally, COVID-19 non-serious event was reported.  The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/BA.5) is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning a 67-year-old male patient with no relevant medical history, who experienced the serious (due to medically significant) unexpected, AESI event of Myocardial infarction, which occurred approximately 3 months after the fifth dose of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine (received other 4 doses of Moderna as previous COVID-19 vaccination schedule). It was reported that according to cardiologist, patient had a mild heart attack. He had no major blockage, and no stent was used. There was a minor damage to lower lobe, insignificant for patient's age according to reporter, if patient maintains healthy diet, exercise, and medications. Concomitant medication reported was acetylsalicylic acid, clopidogrel, metoprolol, rosuvastatin and fenofibrate. Additionally, COVID-19 non-serious event was reported.  The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/BA.5) is not affected by this report.