Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dyspnoea, Expired product administered, Myocardial infarction
Clinical narrative: In the recovery room after the Triple ByPass surgery the patient's Mother suffered a Stroke.; The patient suffered a heart attack on 10OCT2021; days after booster dose patient started having trouble breathing; Patient received expired Covid-19 vaccine/vaccine expired 26SEP2021; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (In the recovery room after the Triple ByPass surgery the patient's Mother suffered a Stroke.), MYOCARDIAL INFARCTION (The patient suffered a heart attack on 10OCT2021) and DYSPNOEA (days after booster dose patient started having trouble breathing) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 05-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Covid-19 vaccine/vaccine expired 26SEP2021). On 09-Oct-2021, the patient experienced DYSPNOEA (days after booster dose patient started having trouble breathing) (seriousness criteria hospitalization and medically significant). On 10-Oct-2021, the patient experienced MYOCARDIAL INFARCTION (The patient suffered a heart attack on 10OCT2021) (seriousness criteria hospitalization and medically significant). On 11-Oct-2021, the patient experienced CEREBROVASCULAR ACCIDENT (In the recovery room after the Triple ByPass surgery the patient's Mother suffered a Stroke.) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (Triple By pass surgery) for Myocardial infarction. On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Covid-19 vaccine/vaccine expired 26SEP2021) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (In the recovery room after the Triple ByPass surgery the patient's Mother suffered a Stroke.), MYOCARDIAL INFARCTION (The patient suffered a heart attack on 10OCT2021) and DYSPNOEA (days after booster dose patient started having trouble breathing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included High Blood Pressure Medication. Treatment details was not reported by the reporter.  Company Comment: This is a spontaneous case of expired product administered for this 76-year-old, female patient with relevant medical history of Hypertension, who experienced the unexpected, serious AESI of cerebrovascular accident and the unexpected, serious events of myocardial infarction and dyspnoea. The events, which resulted in hospitalization, occurred beginning 4 days and up to 6 days after administration of the booster dose of the Moderna mRNA-1273 vaccine. Four days after vaccination, the patient started having trouble breathing. She was brought to the hospital. No further details were provided. However, the patient suffered a heart attack the following day. Later that day, she was transferred to Hospital. On the next day, the patient underwent Triple Bypass surgery. In the recovery room after the surgery, the patient suffered a stroke. No further details were provided. Laboratory tests and medical treatment information were not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The patient's medical history of Hypertension, which is a risk factor for myocardial infarction and stroke, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.   This case was linked to MOD-2021-402980 (Patient Link).; Sender's Comments: This is a spontaneous case of expired product administered for this 76-year-old, female patient with relevant medical history of Hypertension, who experienced the unexpected, serious AESI of cerebrovascular accident and the unexpected, serious events of myocardial infarction and dyspnoea. The events, which resulted in hospitalization, occurred beginning 4 days and up to 6 days after administration of the booster dose of the Moderna mRNA-1273 vaccine. Four days after vaccination, the patient started having trouble breathing. She was brought to the hospital. No further details were provided. However, the patient suffered a heart attack the following day. Later that day, she was transferred to Hospital. On the next day, the patient underwent Triple Bypass surgery. In the recovery room after the surgery, the patient suffered a stroke. No further details were provided. Laboratory tests and medical treatment information were not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The patient's medical history of Hypertension, which is a risk factor for myocardial infarction and stroke, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.