Age: 64.0
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 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) and PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     It was unknown if the patient had ever been diagnosed or 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 (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, 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) and PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) 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).    Concomitant medications details were not reported by the reporter.  Reporter stated that a site that administers the Moderna COVID-19 vaccine did not monitor the freezer temperatures where the Moderna vaccine is stored. The site had a data logger, but it was not set up to record.   The 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.  There were no adverse events. Potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover was reported. The event did not cause the patient to seek medical care.  Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-586994 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Follow up received contain non significant information, quality complaint number was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-586994:Master case