Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 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 an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 2:51 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 2:43 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Mar-2021 at 2:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). In 2021, the patient experienced 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 02-MAR-2021, Excursion time was 9 AM, temp was 27 , total doses given for the day was 177, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-FEB-2021, vial was moved to clinic on 02-MAR-2021. 16 vials were moved to clinic. Vaccine BUD date was 26-MAR-2021.  Vial was stored on cooler 1 ,on 02-MAR-2021, Excursion duration At 9 AM: 27 , 10 AM: 29, 11 AM: 32, 12 PM: 33, 1PM : 36, 2 PM : 35, 3 PM: 36  4 PM: 37 and 5 PM: 37   On 30-Mar-2021, Excursion time was 9 AM, temp was 33 , total doses given for the day was 173, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021.  Vial was stored on cooler 1 , on 30-Mar-2021, Excursion duration At 9 AM: 33, 10 AM: 36, 11 AM:36, 12 PM:40, 1PM : 40, 2 PM : 39, 3 PM: 38, 4 PM: 40 and 5 PM : 40.  Vials only punctured right before administration  Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported