Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error, Product temperature excursion issue
Clinical narrative: Vials transported at refrigerated temp, re-frozen at time of arrival; vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Vials transported at refrigerated temp, re-frozen at time of arrival) and PRODUCT STORAGE ERROR (vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A, 032B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Gout on 09-Oct-2012, Angina pectoris from 29-Sep-2011 to 24-May-2016, Pain in spine on 14-Jul-2014, Kidney transplant from 25-Feb-2011 to 15-Feb-2017, Anticoagulant therapy (INR of 2 to 3,  14 Apr 2021- Current use of long term anticoagulation) on 20-Nov-2018 and Kidney transplant on 14-Nov-2017. Concurrent medical conditions included Allergy to plants (Aloe), Drug allergy (Ampicillin), Drug allergy (Calcitriol), Drug allergy (Lipitor), Hyperlipidemia (with target LDL less than 70) since 15-Jul-2010, Kidney stone (mixed calcium oxalate) since 15-Jul-2010, Hyperuricemia since 26-Jan-2012, Obstructive sleep apnea syndrome (on CPAP) since 18-Jan-2013, Gouty arthritis since 28-Jan-2016, Asthma (mild persistent without complications) since 26-Jun-2017, Coronary artery disease (native coronary artery of native heart without angina pectoris) since 26-Jun-2017, Congestive heart failure (Chronic diastolic CHF) since 12-Sep-2017, Mood disorder since 30-Sep-2019, Wrist osteoarthritis (Arthritis of left wrist) since 30-Dec-2019, Benign essential hypertension since 14-Nov-2017, Magnesium metabolism disorder since 14-Nov-2017, Lung nodule (Multiple nodules of lung) since 14-Nov-2017, Transient cerebral ischemia since 14-Nov-2017, Atrial fibrillation since 14-Nov-2017, Anemia since 14-Nov-2017, Skin neoplasm malignant (unspecified sites of skin) since 14-Nov-2017, Obesity (Class 3 Obesity), Basal cell carcinoma (left side of nose) since 31-Dec-2021, Gouty arthropathy (chronic without tophi) since 31-Oct-2021, Acidosis since 27-Jul-2021, Schatzki's ring, Colonic polyp, Barrett's esophagus, Deafness, Small bowel obstruction and Immunocompromised.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vials transported at refrigerated temp, re-frozen at time of arrival) and PRODUCT STORAGE ERROR (vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Vials transported at refrigerated temp, re-frozen at time of arrival) and PRODUCT STORAGE ERROR (vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. On 16-Jun-2021, moderna vial (lot 032B21A) were delivered at refrigerator temperature. The reporter stated that the office was unaware that vial was not shipped frozen and staff put vial back into freezer when arrived on morning of 16-Jun-2021. Transport temperature was between 2 to 8 degrees Celsius for couple of hours. Vial was then set out on 27-Aug-2021 to thaw for one hour to room temperature. Patient had no signs or symptoms of any adverse reactions to the injection given. No treatment medication were provided. Patient did not seek medical care.   This case was linked to MOD-2022-527362 (Patient Link).