Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue, Troponin
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose was given beyond 30 days), PRODUCT STORAGE ERROR (Vial was not shipped frozen and put back into freezer/ vaccine given beyond 30 days from refrigeration) and PRODUCT TEMPERATURE EXCURSION ISSUE (The office was unaware that the vial was not shipped frozen, staff put vial back into freezer when arrived.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 004F21A) for COVID-19 vaccination. Patient had long term current use of anticoagulant therapy from 18 Aug 2015 to 10 Apr 2017, Chronic anticoagulation from 10 Nov 2016. On 25 Nov 2016 patient reported Pulmonary embolism(PE).  The patient's past medical history included Coffee ground emesis from 10-Nov-2016 to 10-Apr-2017, Pulmonary embolism (Bilateral pulmonary embolism (HCC)) from 19-Nov-2016 to 10-Apr-2017, GI bleed on 19-Nov-2016, Debility on 19-Nov-2016, Acute blood loss anemia from 20-Nov-2016 to 10-Apr-2017, Iron deficiency from 21-Nov-2016 to 10-Apr-2017, Hypoxia on 07-Oct-2017, Pneumonia (Pneumonia RLL) on 07-Oct-2017, Essential hypertension, benign on 11-Oct-2017, Diarrhea on 11-Oct-2017, Folate deficiency anaemia (Anemia, B12 and folate deficiency + chronic disease) on 12-Oct-2017, B12 deficiency anaemia (Anemia, B12 and folate deficiency + chronic disease) on 12-Oct-2017, Coronary artery disease (Coronary artery disease involving native coronary artery with angina pectoris) on 15-Jul-2019, Angina pectoris (Coronary artery disease involving native coronary artery with angina pectoris) on 15-Jul-2019, Closed fracture (Closed fracture of proximal end of right humerus with routine healing) on 11-Dec-2020, Palliative care (Palliative care patient) on 12-May-2020 and Iron deficiency anemia secondary to blood loss (chronic) (Iron deficiency anemia due to chronic blood loss) on 25-Nov-2016. Concurrent medical conditions included Drug allergy (Aspirin Allergy), Drug allergy (Codeine Allergy), Drug allergy (Folic acid Allergy), Drug allergy (Iron Allergy), Penicillin allergy (Penicillin allergy), Osteoporosis since 07-Dec-2015, Drug allergy (Cortisol allergy), Hiatal hernia since 11-Nov-2016, Superficial gastritis (Chronic superficial gastritis with bleeding) since 11-Nov-2016, Aortic stenosis since 19-Nov-2016, COPD since 10-Apr-2017, Congestive heart failure (Diastolic CHF, acute (HCC)) since 08-Oct-2017 and Acute on chronic heart failure (Acute on chronic diastolic CHF(Congestive heart failure) (HCC)) since 09-May-2019. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was given beyond 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was not shipped frozen and put back into freezer/ vaccine given beyond 30 days from refrigeration) and PRODUCT TEMPERATURE EXCURSION ISSUE (The office was unaware that the vial was not shipped frozen, staff put vial back into freezer when arrived.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose was given beyond 30 days), PRODUCT STORAGE ERROR (Vial was not shipped frozen and put back into freezer/ vaccine given beyond 30 days from refrigeration) and PRODUCT TEMPERATURE EXCURSION ISSUE (The office was unaware that the vial was not shipped frozen, staff put vial back into freezer when arrived) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2017, Troponin: elevated (High) Elevated Troponin. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT TEMPERATURE EXCURSION ISSUE (The office was unaware that the vial was not shipped frozen, staff put vial back into freezer when arrived) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The dose was given beyond 30 days) and PRODUCT STORAGE ERROR (Vial was not shipped frozen and put back into freezer/ vaccine given beyond 30 days from refrigeration). On 04 Feb 2022, patient reported Acute on chronic respiratory failure (HCC), and Hypertensive emergency. Delivery of the vial at refrigerator temperature was on 16 Jun 2021. Office was unaware that the vial was not shipped frozen, and put vial back into freezer when arrived morning of 16 Jun 2021. Transport temperature was between 2-8 C for couple of hours. Vial was then set out on 23 Aug 2021 to thaw for one hour at room temperature. Dose of 0.5ml then given to patient on 23 Aug 2021. No treatment drug details was reported.