Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Does not monitor freezer temperatures/Possible freezer temperature excursion; Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/Potential sub potent dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/Potential sub potent dose.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion) in an 82-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 was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/Potential sub potent dose.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/Potential sub potent dose.) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/Potential sub potent 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).    Concomitant medications details were not reported by the reporter. It was reported that vaccines were stored, there were no monitoring of  the freezer temperature and those vaccines were administered to patients. Vaccination site had a data logger, but it was not set up to record. The HCP stated that there were no freezer minimum and maximum temperatures to report as the temperatures were 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. Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Live follow-up: Quality complaint number received.