Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown; Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential subpotent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential subpotent dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential subpotent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential subpotent dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential subpotent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown).    No concomitant medications were reported.  The patient administered the Moderna COVID-19 vaccine which was stored in freezer for which temperature was not monitor. The site had a data logger, but it was not set up to record. The health care professional (HCP) stated there was no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site. Therefore, it was unknown if a freezer temperature excursion actually occurred.  The event potential sub potent dose did not cause patient to seek medical care.  There were no adverse events reported. Only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Live follow up received quality complaint number added.