Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Possible temperature excursion incidence; The vial was administered more than 30 days after the vial was first removed from frozen storage; The vial was administered more than 30 days after the vial was first removed from frozen storage; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was administered more than 30 days after the vial was first removed from frozen storage), PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion incidence) and PRODUCT STORAGE ERROR (The vial was administered more than 30 days after the vial was first removed from frozen storage) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     The patient never been diagnosed with or tested positive for COVID-19. No acute illnesses at the time of vaccination and up to one month before. No Chronic or long-standing health conditions. No over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.     On 24-Mar-2022 at 2:24 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Mar-2022 at 2:24 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was administered more than 30 days after the vial was first removed from frozen storage). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion incidence) and PRODUCT STORAGE ERROR (The vial was administered more than 30 days after the vial was first removed from frozen storage). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was administered more than 30 days after the vial was first removed from frozen storage), PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion incidence) and PRODUCT STORAGE ERROR (The vial was administered more than 30 days after the vial was first removed from frozen storage) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (The vial was administered more than 30 days after the vial was first removed from frozen storage) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion incidence) and PRODUCT STORAGE ERROR (The vial was administered more than 30 days after the vial was first removed from frozen storage).    No concomitant medications were provided.  It was reported that staff immediately refroze the vial and administered the dose to the patient.    Upon request, Moderna Inc, manufacturer for Spikevax, had completed an investigation (Case ID CEA-2076) on the Viability of this Lot 069H21A following this "possible temperature excursion incidence".  On 07-Apr-2022 Moderna Inc, has determined that "Analysis of the vials associated with your storage excursion is complete. The vaccine administered on or before 24-Mar-2022, from lot number 069H21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."  There were no other potential causes and patient did not experience similar event in the past.  It was stated that, event did not cause patient to seek medical care.  Patient did not experience, similar event in past.  The patient did not report adverse reaction.  No treatment medications was provided.