Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 74.49.  Concomitant products were not provided.   On 31-Mar-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day were 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 31-Mar-2021, vial was moved to clinic on 30-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  Vial was stored in cooler 1, on 30-Mar-2021, temperature excursion at 9 AM: 33, 10 AM: 36, 11 AM: 36, 12 AM: 40, 1PM: 40, 2 PM: 39, 3 PM: 38, 4 PM: 40 and 5 PM: 40.   Vial was stored in cooler 1, on 31-Mar-2021, temperature excursion at 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46, 4 PM: 44 and 5 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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.