Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Temperature was around 0-1 degree C. The vial was refrozen immediately; Vial was removed from the frozen storage on 10-Feb-2022 and was administered on 17-Mar-2022, after 35 days; The vaccine first removed from frozen storage on 10-Feb-2022 and administered on 17-Mar-2022, after 35 days; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine first removed from frozen storage on 10-Feb-2022 and administered on 17-Mar-2022, after 35 days), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature was around 0-1 degree C. The vial was refrozen immediately) and PRODUCT STORAGE ERROR (Vial was removed from the frozen storage on 10-Feb-2022 and was administered on 17-Mar-2022, after 35 days) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Patient has never been diagnosed or tested positive for COVID-19. Acute illness at the time of vaccination ad up to one month before was reported as none. No chronic or long standing health conditions were reported.     On 17-Mar-2022 at 3:36 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Mar-2022 at 3:36 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine first removed from frozen storage on 10-Feb-2022 and administered on 17-Mar-2022, after 35 days). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature was around 0-1 degree C. The vial was refrozen immediately) and PRODUCT STORAGE ERROR (Vial was removed from the frozen storage on 10-Feb-2022 and was administered on 17-Mar-2022, after 35 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine first removed from frozen storage on 10-Feb-2022 and administered on 17-Mar-2022, after 35 days), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature was around 0-1 degree C. The vial was refrozen immediately) and PRODUCT STORAGE ERROR (Vial was removed from the frozen storage on 10-Feb-2022 and was administered on 17-Mar-2022, after 35 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (The vaccine first removed from frozen storage on 10-Feb-2022 and administered on 17-Mar-2022, after 35 days) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature was around 0-1 degree C. The vial was refrozen immediately) and PRODUCT STORAGE ERROR (Vial was removed from the frozen storage on 10-Feb-2022 and was administered on 17-Mar-2022, after 35 days).    Prescription, over the counter medications dietary supplements, or herbal remedies being taken at the time of vaccination or at the time of adverse event was reported as none.  Patient did not seek any medical care. There were no potential causes reported for the event. The vial was first removed from the frozen storage on 10-Feb-2022 and was administered after 35 days, on 17-Mar-2022. The temperature was around 0-1 degree Celsius. The patient did not report any adverse reaction, no positive COVID test not COVID disease till 25-Apr -2022. It was reported that the Moderna Inc manufacturer for spike ax had completed an investigation on the viability of the lot 069H21A following the possible temperature excursion incidence. On 7-Apr-2022 it was determined that analysis of the vial associated with storage excursion was completed. the vaccine which was administered on or before 24-Mar-2022 from lot no. 069H21A maintained the activity necessary to protect against SARS-CoV-2 (COVID-19) Virus at the time of administration.  No treatment medication information provided.