Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Magnetic resonance imaging, Myocardial infarction, Paralysis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (3 heart attacks back to back after second shot/ severe chest pain/ trouble breathing/ severe contractions), PARALYSIS (her whole body was paralyzed), VISION BLURRED (vision would blur up) and CHEST PAIN (Still have chest pains) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 020B21A) for COVID-19 vaccination. The patient's past medical history included C-section (Two), Finger operation (in high school), Surgery and Stent placement. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced PARALYSIS (her whole body was paralyzed) (seriousness criteria hospitalization and medically significant), VISION BLURRED (vision would blur up) (seriousness criterion hospitalization) and CHEST PAIN (Still have chest pains) (seriousness criterion hospitalization). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (3 heart attacks back to back after second shot/ severe chest pain/ trouble breathing/ severe contractions) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-Apr-2022 to 09-Apr-2022 due to CHEST PAIN, MYOCARDIAL INFARCTION, PARALYSIS and VISION BLURRED. The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at a dose of 81 milligram; ATORVASTATIN ongoing since an unknown date at a dose of 40 milligram twice a day; PANTOPRAZOLE ongoing since an unknown date at a dose of 40 milligram once a day; TICAGRELOR (BRILINTA) ongoing since an unknown date at a dose of 90 milligram; NITROGLYCERIN ongoing since an unknown date for Chest pain, at a dose of 0.4 milligram (every 5 minutes as needed for chest pain 3 doses) and NIFEDIPINE at a dose of 30 milligram once a day. At the time of the report, MYOCARDIAL INFARCTION (3 heart attacks back to back after second shot/ severe chest pain/ trouble breathing/ severe contractions) had resolved, PARALYSIS (her whole body was paralyzed) and VISION BLURRED (vision would blur up) outcome was unknown and CHEST PAIN (Still have chest pains) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: results not provided Results not provided. On an unknown date, Magnetic resonance imaging: results not provided Results not provided. Patient states that she had been very healthy and never had any health issues or past medical history. She states that she is not able to work and pay for her medical bills now and had two kids who is depended on her and Currently she is on multiple medications. No allergies were reported. Never had COVID or COVID related symptoms. No history related to mentioned AE and both acute and chronic illnesses at the time of vaccination were reported. No other vaccine were given one month prior to Moderna COVID-19 vaccine. Patient received only Moderna COVID-19 brand vaccines. Patient still have chest pains and doctor's states that the heart attack was caused by the Moderna COVID-19 vaccine. Patient couldn't remember experiencing any other cardiac related signs and symptoms other than severe chest pain and trouble breathing. It was reported that the patient didn't have any cardiac lab reports even though she said that she did every test possible. There was no history of Myocarditis/pericarditis. Reporter did not allow further contact. Company Comment: This spontaneous case concerns a 42 year old female patient with no relevant medical history reported. who experienced Serious  (medically significant, hospitalization), unexpected, AESI of myocardial infarction ((3 heart attacks back to back after second shot/ severe chest pain/ trouble breathing/ severe contractions) which occurred on an unknown date post vaccination with the 2nd dose of mRNA-1273 vaccine . This was accompanied by other Serious ( hospitalization) , unexpected events of paralysis, vision blurred and chest pain which occurred on the same day post vaccination with the 2nd dose of mRNA-1273 vaccine. The first dose of Covid-19 vaccine of this patient was also a mRNA-1273 vaccine. She was admitted to the ER and hospitalized for 2 days from 7April2022-9April2022 and she underwent coronary stenting two stents were placed. She is on multiple medications namely: Aspirin 81mg, Atorvastatin 40mg tablet twice at bedtime, Pantoprazole 40mg 1 tablet daily, Brilinta 90mg, Nitroglycerin 0.4mg every 5 minutes as needed for chest pain 3 doses which was later  discontinued: nifedipine 30mg one tablet per day. Other details of the hospitalization including results of the laboratories/diagnostic procedures were not reported although she mentioned that every test possible was done for her. Outcome of the event Myocardial Infarction was  reported as resolved while the other events paralysis, Vison blurred and chest pain has not resolved. Patient still have chest pains and doctor's states that the heart attack was caused by the Moderna COVID-19 vaccine. Patient also reported she is unable to work. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. Sender's Comments: This spontaneous case concerns a 42 year old female patient with no relevant medical history reported. who experienced Serious (medically significant, hospitalization), unexpected, AESI of myocardial infarction ((3 heart attacks back to back after second shot/ severe chest pain/ trouble breathing/ severe contractions) which occurred on an unknown date post vaccination with the 2nd dose of mRNA-1273 vaccine. This was accompanied by other Serious (hospitalization), unexpected events of  paralysis, vision blurred and chest pain which occurred on the same day post vaccination with the 2nd dose of mRNA-1273 vaccine. The first dose of Covid-19 vaccine of this patient was also a mRNA-1273 vaccine. She was admitted to the ER and hospitalized for 2 days from 7April2022-9April2022 and she underwent coronary stenting two stents were placed. She is on multiple medications namely: Aspirin 81mg, Atorvastatin 40mg tablet twice at bedtime, Pantoprazole 40mg 1 tablet daily, Brilinta 90mg, Nitroglycerin 0.4mg every 5 minutes as needed for chest pain 3 doses which was later discontinued: nifedipine 30mg one tablet per day. Other details of the hospitalization including results of the laboratories/diagnostic procedures were not reported although she mentioned that every test possible was done for her. Outcome of the event Myocardial Infarction was reported as resolved while the other events paralysis, Vison blurred and chest pain has not resolved. Patient still have chest pains and doctor's states that the heart attack was caused by the Moderna COVID-19 vaccine. Patient also reported she is unable to work. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.