Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover/Potential sub potent dose.; Does not monitor freezer temperatures/Possible freezer temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover/Potential sub potent dose.) and POOR QUALITY PRODUCT ADMINISTERED (Does not monitor freezer temperatures/Possible freezer temperature excursion) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     It was unknown  if patient had ever been diagnosed with/ tested positive for COVID-19.     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 (Does not monitor freezer temperatures/Possible freezer temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover/Potential sub potent dose.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover/Potential sub potent dose.) and POOR QUALITY PRODUCT ADMINISTERED (Does not monitor freezer temperatures/Possible freezer temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Does not monitor freezer temperatures/Possible freezer temperature excursion) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover/Potential sub potent dose.).    No concomitant medications were reported  It was reported that vaccines was stored, there was no monitoring of  the freezer temperature and those vaccines was administered to patients. Vaccination site has a data logger, but it was not set up to record.  The HCP stated that there is no freezer minimum and maximum temperatures to report as the temperatures are not recorded by the site.  There were no adverse event, only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover. The event did not cause the patient to seek medical care.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Live Follow-up received contain non significant information Quality complaint number received.