Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Potential AE due to doses administered from vials that may have been compromised.; Administered vaccine from vials that may have been compromised.; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Approve date 01-Nov-2021 and conservative beyond use date (BUD) was 01-Dec-2021.  No concomitant medications was reported.  Reporter stated that they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed. They were preparing for a CDC audit and wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures. Reporter queried whether they need to take any action since they stored them in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment information was reported.   This case was linked to MOD-2022-572536, MOD-2022-572568, MOD-2022-572638, MOD-2022-572392, MOD-2022-572647, MOD-2022-572564, MOD-2022-572569 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Follow-up document contains no additional information. On 20-May-2022: Follow up received. Added event (Vaccination site reaction) and narrative.