Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Blood pressure systolic, Hypertension, Tachycardia
Clinical narrative: NSTEMI/MI plus chest pains; Elevated systolic pressure; Tachycardia; This spontaneous case was reported by a nurse and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (NSTEMI/MI plus chest pains), HYPERTENSION (Elevated systolic pressure) and TACHYCARDIA (Tachycardia) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis.     The patient's past medical history included Seizures. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Lot no: EL3249 Exp: 06/30/21) on 18-Jan-2021, Pfizer (Dose:2, Lot no: EL8982, Exp: 05/31/21) on 08-Feb-2021, Pfizer Bivalent (Dose:5, Lot no: GJ2524 and Exp: 10/14/22) on 20-Sep-2022; for COVID-19 prophylaxis: Moderna (Dose 3, Lot no: 030H21B, Exp: 01/02/22) on 17-Dec-2021, Moderna (Dose 4, Lot no: 017B22A and Exp: 07/24/22) on 30-Jun-2022. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Pfizer, Pfizer and Pfizer Bivalent. Concurrent medical conditions included Allergy to antibiotic, Allergic reaction to drug, Iodine contrast media allergy, Dementia, Heart failure, congestive, Hyperlipidemia, Hypertension, Constipation, Pain, Dry eyes, Major depressive disorder (RECURRENT, MODERATE (F33.1)) and COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for COPD, FUROSEMIDE (LASIX [FUROSEMIDE]) for Congestive heart failure, MACROGOL 3350 (MIRALAX) for Constipation, DONEPEZIL HYDROCHLORIDE (ARICEPT) for Dementia, OLOPATADINE HYDROCHLORIDE (PATADAY) for Dry eyes, PHENYTOIN and PHENYTOIN SODIUM for Epilepsy, unspecified, ATORVASTATIN CALCIUM (LIPITOR) for Hyperlipidemia, LISINOPRIL for Hypertension, SERTRALINE HCL for Major depressive disorder, recurrent episode, GABAPENTIN (NEURONTIN [GABAPENTIN]) and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Pain, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Seizures, CALCIUM CARBONATE, COLECALCIFEROL (OSCAL D [CALCIUM CARBONATE;COLECALCIFEROL]) for Supplementation therapy.    On 07-Nov-2023 at 9:16 AM, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 07-Nov-2023 at 11:30 AM, the patient experienced ACUTE MYOCARDIAL INFARCTION (NSTEMI/MI plus chest pains) (seriousness criteria hospitalization, medically significant and life threatening), HYPERTENSION (Elevated systolic pressure) (seriousness criteria hospitalization and life threatening) and TACHYCARDIA (Tachycardia) (seriousness criteria hospitalization and life threatening). The patient was hospitalized for 3 days due to ACUTE MYOCARDIAL INFARCTION, HYPERTENSION and TACHYCARDIA. The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) (oral use) for NSTEMI, at a dose of 81 milligram once a day. At the time of the report, ACUTE MYOCARDIAL INFARCTION (NSTEMI/MI plus chest pains), HYPERTENSION (Elevated systolic pressure) and TACHYCARDIA (Tachycardia) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Nov-2023, Blood pressure systolic: elevated.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Company comment-This spontaneous case concerns a 72-year-old female patient, with concurrent conditions of chronic heart failure, hypercholesterolemia and hypertension, who experienced the unexpected serious (life threatening, hospitalization and medically significant) AESI acute myocardial infarction and the unexpected and serious (life threatening and hospitalization) events tachycardia and hypertension approximately 2 hours after a dose of SPIKEVAX 2023-2024 vaccine, given as a sixth dose of COVID vaccine schedule, was administered. Patient received previously three doses of TOZINAMERAN vaccine and two doses of mRNA-1273 vaccine (revaccination with different COVID-19 vaccine and interchange of vaccine product). It was reported patient experienced chest pain, elevated systolic pressure and tachycardia and was hospitalized. No further details were provided for medical review. Concurrent conditions of chronic heart failure, hypercholesterolemia and hypertension along with patient´s age remain as contributory risk factors for the events. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-749140, US-MODERNATX, INC.-MOD-2023-749726 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2023: Live significant follow-up received. LOT number updated. On 10-Nov-2023: Live follow-up received with significant information. Patient details, previous vaccine details and suspect product information updated. On 10-Nov-2023: Live follow-up received with significant information. Patient, reporter details, medical history, concomitant medications, lab data, events and narrative updated. On 13-Nov-2023: Live follow-up received that contains significant information: Reference ids updated. On 13-Nov-2023: Live Significant follow up added. Reporter was added. Patient age group added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749140:Master case US-MODERNATX, INC.-MOD-2023-749726:Deleted case