Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; 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; 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), PRODUCT STORAGE ERROR (vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials transported at refrigerated temp, re-frozen at time of arrival) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 004F21A) for COVID-19 vaccination.     It was unknown if patient had ever tested/diagnosed positive for Covid-19. The acute illnesses at time of vaccination or 1 month before vaccination were unknown.  The patient's past medical history included Cervical stricture from 05-Oct-2015 to 12-Dec-2016, Cervical spondylosis from 19-Feb-2016 to 23-Aug-2021, Cigarette smoker on 12-Dec-2016 and Coronary arterial stent insertion on 12-Dec-2016. Concurrent medical conditions included Drug allergy (Antihistamine), Drug allergy (Decongestant), Osteoarthritis of neck since 21-Jul-2015, Coronary artery disease (due to lipid rich plaque) since 21-Jul-2015, Hypercholesteremia since 21-Jul-2015, Depression since 21-Jul-2015, Hypothyroidism since 19-Feb-2016, Thyroid atrophy since 19-Feb-2016, Recurrent depressive disorder (in remission (HCC)) since 12-Dec-2016, Cigar smoker since 12-Dec-2016 and Chronic pain since 22-Sep-2017.   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 (vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials transported at refrigerated temp, re-frozen at time of arrival). 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), PRODUCT STORAGE ERROR (vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT TEMPERATURE EXCURSION ISSUE (Vials transported at refrigerated temp, re-frozen at time of arrival) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT STORAGE ERROR (vials received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients).    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 23-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).