Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Asymptomatic COVID-19, Blood iron, Blood pressure measurement, Cardiac arrest
Clinical narrative: Cardiac arrest; Anaemia; Hyperglycaemia; Asymptomatic covid-19; Interchange of vaccine products; This spontaneous case was reported by an other health care professional and describes the occurrence of CARDIAC ARREST (Cardiac arrest), ANAEMIA (Anaemia), HYPERGLYCAEMIA (Hyperglycaemia) and ASYMPTOMATIC COVID-19 (Asymptomatic covid-19) in a 59-year-old female patient who received mRNA-1273 (Spikevax) (batch no. CVX207) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) suspension for injection for an unknown indication.    The patient's past medical history included Non STEMI in May 2021, Anxiety, Depression, Alcohol abuse, Gallstones, Foot drop, Wound infection, Plantar fasciitis, Polyneuropathy, Insomnia, Stent thrombosis, Stent replacement (2 times (multiple stents)) in 2018, Surgery, Toe amputation and Cardiac operation. Concurrent medical conditions included Smoker, Coronary artery disease (Involving the native coronary artery status post NSTEMI), Ischaemic cardiomyopathy, Mitral stenosis, Essential hypertension (status post NSTEMI), Dyslipidemia, Diabetes mellitus, Peripheral vascular disorder, Cardiomyopathy, Carotid artery stenosis, Atherosclerosis of aorta, Hives, Muscle disorder, Dyslipidaemia (status post NSTEMI), Coronary artery occlusion, Heart failure with reduced ejection fraction (EF 20-25 %), Hyperlipidemia, Allergy to intravenous contrast media (Allergy to iv dyes  (iodinated contrast media)), Drug allergy (Allergy to Lipitor (Atorvastatin)) and Drug allergy (allergy to Pravastatin and Rosuvastatin). Concomitant products included APIXABAN (ELIQUIS), ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL BISULFATE (PLAVIX), ISOSORBIDE MONONITRATE (IMDUR), ALBUTEROL [SALBUTAMOL], ALPHA LIPOIC ACID, ALPRAZOLAM (XANAX), AMIODARONE HYDROCHLORIDE (PACERONE), CARVEDILOL (COREG), VITAMIN D3, DICLOFENAC (VOLTAREN [DICLOFENAC]), DICYCLOVERINE HYDROCHLORIDE (BENTYL), DULOXETINE HYDROCHLORIDE (CYMBALTA), EVOLOCUMAB (REPATHA), FERROUS SULFATE (FEOSOL), FOLIC ACID, FUROSEMIDE (LASIX [FUROSEMIDE]), GABAPENTIN (NEURONTIN), LISINOPRIL, CANNABIS, GLYCERYL TRINITRATE (NITROSTAT), OXCARBAZEPINE (TRILEPTAL), THIAMINE HYDROCHLORIDE (VITAMIN B1) and TOLTERODINE L-TARTRATE (DETROL) for an unknown indication.   On 08-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient started COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form once a day. On 08-Mar-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 11-Mar-2022, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization and medically significant), ANAEMIA (Anaemia) (seriousness criterion hospitalization), HYPERGLYCAEMIA (Hyperglycaemia) (seriousness criterion hospitalization) and ASYMPTOMATIC COVID-19 (Asymptomatic covid-19) (seriousness criterion hospitalization). The patient was hospitalized from 11-Mar-2022 to 30-Mar-2022 due to ANAEMIA, ASYMPTOMATIC COVID-19, CARDIAC ARREST and HYPERGLYCAEMIA. The patient was treated with RED BLOOD CELLS for Anemia, at an unspecified dose and frequency; AMIODARONE at an unspecified dose and frequency and Manual therapy (Therapeutic hypothermia,Resuscitation,) for Cardiac arrest. At the time of the report, CARDIAC ARREST (Cardiac arrest), ANAEMIA (Anaemia), HYPERGLYCAEMIA (Hyperglycaemia) and ASYMPTOMATIC COVID-19 (Asymptomatic covid-19) had resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2022, Blood iron: low (Low) Low. On 11-Mar-2022, Blood pressure measurement: borderline low bp borderline low BP. On 11-Mar-2022, Catheterisation cardiac: abnormal Abnormal. On 11-Mar-2022, Glycosylated haemoglobin: 6.2 (normal) 6.2. On 11-Mar-2022, SARS-CoV-2 test: covid detected COVID detected. On an unknown date, Ejection fraction: 20-25 percentage 20-25 percentage.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   On 11-Mar-2022, 3 days after receiving the Moderna vaccination, the patient was admitted with cardiac arrest (dose 2). A COVID-19 ECR (coronavirus polymerase chain reaction) test was done upon admission as a part of routine admission testing and COVID-19 was detected (SARS-CoV-2 test positive) (dose 2). The patient was asymptomatic (Asymptomatic COVID-19) (dose 2). The patient was resuscitated in the field. The patient had therapeutic hypothermia and underwent hypothermia protocol and had left heart catheterization (LEC) with percutaneous coronary intervention (PCI) twice with drug eluting stent (DES) in mid and distal left anterior descending artery (LAD) on 25-MAR-2022 (dose 2). Cardiology was consulted and patient was placed on amiodarone and automatic implantable cardioverter-defibrillator (AICD) on 29-Mar-2022 (dose 2). Medications were reconciled as per cardiology instructions. Apixaban, acetylsalicylic acid and clopidogrel bisulfate were to be continued for 1 more month and then could be de-escalated as per cardiology instructions. The patient was to follow up closely with cardiology. Isosorbide mononitrate was held due to borderline low blood pressure. Patient was cleared for discharged on an unspecified date and was recommended to got to skilled nursing facility to which the patient declined in favor of going home. The patient knew that it could render additional risks including but not limited to falls medication noncompliance or worsening of disease which could be life threatening. The patient was given 2 units of packed red blood cells for anemia which had stabilized at the time of report and received iron supplementation due to low iron levels. Patient was hyperglycemic with her acute illness (dose 2). The patient was hospitalized for 20 days and discharged on an unspecified date. The patient received anticoagulant therapy; her glycosylated hemoglobin was normal. Her cardiac catheterization was abnormal (dose 2).  Company Comment:  This spontaneous case concerns 59-year-old female patient with medical history of Smoker, Coronary artery disease (Involving the native coronary artery status post NSTEMI), Ischaemic cardiomyopathy, Mitral stenosis, Essential hypertension (status post NSTEMI), Dyslipidemia, Diabetes mellitus, Peripheral vascular disorder, Cardiomyopathy, Carotid artery stenosis, Atherosclerosis of aorta, Heart failure with reduced ejection fraction, who experienced the unexpected, serious (due to medically significant and hospitalization) events of cardiac arrest, anaemia, hyperglycaemia and asymptomatic COVID-19, which occurred 3 days after the 2nd dose of the mRNA-1273 vaccine. The patient was resuscitated in the field, stents were placed. Cardiology was consulted and patient was placed on amiodarone and automatic implantable cardioverter-defibrillator. The patient was treated with Apixaban, acetylsalicylic acid and clopidogrel bisulfate. The patient was given 2 units of packed red blood cells for anemia which had stabilized at the time of report and received iron supplementation due to low iron levels. Patient was hyperglycemic with her acute illness. The patient was hospitalized for 20 days and discharged. All the mentioned medical history could be a contributory risk factor for the event cardiac arrest. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reporter's Comments: VO: 20220417849- covid-19 vaccine ad26.cov2.s -cardiac arrest, hyperglycaemia, stent placement, implantable defibrillator insertion, resuscitation, percutaneous coronary intervention, catheterisation cardiac abnormal, anticoagulant: therapy, glycosylated haemoglobin normal, anaemia and red blood cell transfusion. The event (s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event (s) than the drug. Specifically: MEDICAL HISTORY [cardiac history, diabetes]. Therefore, this event (s) is considered not related. 20220417849-covid-19 vaccine ad26.cov2.s - asymptomatic covid-19, therapeutic hypothermia, and sars -cov-2 test positive. The event (s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event (s) is considered unassessable.; Sender's Comments: This spontaneous case concerns 59-year-old female patient with medical history of Smoker, Coronary artery disease (Involving the native coronary artery status post NSTEMI), Ischaemic cardiomyopathy, Mitral stenosis, Essential hypertension (status post NSTEMI), Dyslipidemia, Diabetes mellitus, Peripheral vascular disorder, Cardiomyopathy, Carotid artery stenosis, Atherosclerosis of aorta, Heart failure with reduced ejection fraction, who experienced the unexpected, serious (due to medically significant and hospitalization) events of cardiac arrest, anaemia, hyperglycaemia and asymptomatic COVID-19, which occurred 3 days after the 2nd dose of the mRNA-1273 vaccine. The patient was resuscitated in the field, stents were placed. Cardiology was consulted and patient was placed on amiodarone and automatic implantable cardioverter-defibrillator. The patient was treated with Apixaban, acetylsalicylic acid and clopidogrel bisulfate. The patient was given 2 units of packed red blood cells for anemia which had stabilized at the time of report and received iron supplementation due to low iron levels. Patient was hyperglycemic with her acute illness. The patient was hospitalized for 20 days and discharged. All the mentioned medical history could be a contributory risk factor for the event cardiac arrest. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.