Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Myocardial infarction
Clinical narrative: Heart attack; Sickness; On 21 Mar 2021, patient received 1st dose COVID-19 Vaccine manufactured by Moderna. On 13 Apr 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Moderna; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) powder for injection for Panuveitis.    No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 13-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 21 Mar 2021, patient received 1st dose COVID-19 Vaccine manufactured by Moderna. On 13 Apr 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Moderna). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant) and ILLNESS (Sickness). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and ILLNESS (Sickness) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 21 Mar 2021, patient received 1st dose COVID-19 Vaccine manufactured by Moderna. On 13 Apr 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Moderna) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant Drugs Not Reported. No treatment information was provided. Patient had a heart attack and she felt sick after her second injection. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This spontaneous case concerns an 86  year  old female patient, with no relevant medical history reported, who received two doses of mRNA-1273 vaccine (doses 1 and 2 were administered in an inappropriate schedule of vaccination) and experienced the serious medically significant unexpected AESI of myocardial infarction. Onset date of the event was not reported; hence latency and temporal association cannot be properly assessed. The reporter mentioned the patient felt ill and had a heart attack. No further clinical information regarding have been provided for medical review. Patient´s age and  Co-suspect product Adalimumab could be risk factors for the event. The benefit risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2022: Significant live follow up (Narrative description updated); Sender's Comments: This spontaneous case concerns an 86  year  old female patient, with no relevant medical history reported, who received two doses of mRNA-1273 vaccine (doses 1 and 2 were administered in an inappropriate schedule of vaccination) and experienced the serious medically significant unexpected AESI of myocardial infarction. Onset date of the event was not reported; hence latency and temporal association cannot be properly assessed. The reporter mentioned the patient felt ill and had a heart attack. No further clinical information regarding have been provided for medical review. Patient´s age and  Co-suspect product Adalimumab could be risk factors for the event. The benefit risk relationship of mRNA-1273 is not affected by this report.