Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered more than 12 hours after first puncture/vial stored in refrigerator for less than 30 days; Patient received Dose 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Dose 12 hours post puncture) and PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after first puncture/vial stored in refrigerator for less than 30 days) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A, 066F21A, 011A21A and 037K20A) for COVID-19 prophylaxis.     Patient never had COVID positive test or diagnosis.  The patient's past medical history included Skin cancer and Defibrillator/pacemaker insertion (Cardiac Defibrillator in place). Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Drug intolerance (Intolerance ace inhibitors (cough)), Drug allergy (Atorvastatin, Zetia, Pravastatin, Pitavastatin), Coronary artery disease, Heart failure, Hypertension pulmonary, Diabetes, Atrial fibrillation, Obstructive sleep apnea syndrome and Iodine allergy. Concomitant products included GLYCERYL TRINITRATE (NITROSTAT) for Chest pain, CLOPIDOGREL BISULFATE (PLAVIX), APIXABAN (ELIQUIS), EVOLOCUMAB (REPATHA) and LOSARTAN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 29-Jun-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 29-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Dose 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after first puncture/vial stored in refrigerator for less than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Dose 12 hours post puncture) and PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after first puncture/vial stored in refrigerator for less than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient height was 5.9. Patient never had COVID + test or diagnosis. The total number of vials were 1. The vial was initially stored in the refrigerator on 09-Jun-2022. The vial was punctured on 28-Jun-2022 at 8:40 am and it was administered 29-Jun-2022 at 3 pm. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 5 minutes. No treatment medications were reported.