Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Poor quality product administered, Product measured potency issue, Product temperature excursion issue
Clinical narrative: Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown; Possible freezer temperature excursion but unknown; Multiple patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover./potential subpotent doses; 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), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible freezer temperature excursion but unknown), POOR QUALITY PRODUCT ADMINISTERED (Multiple patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover./potential subpotent doses) and PRODUCT MEASURED POTENCY ISSUE (Potential subpotent dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     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 (Multiple patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover./potential subpotent doses) and PRODUCT MEASURED POTENCY ISSUE (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) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (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), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Multiple patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover./potential subpotent doses) outcome was unknown and PRODUCT MEASURED POTENCY ISSUE (Potential subpotent dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT MEASURED POTENCY ISSUE (Potential subpotent dose) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Multiple patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover./potential subpotent doses).    Concomitant medications details were not reported by the reporter.  patient ever been diagnosed with/ tested positive for COVID-19 was reported as unknown.   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.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Follow up received contain Non-significant information, Quality complaint number was updated.