Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; patients were administered with vaccines 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 PRODUCT TEMPERATURE EXCURSION ISSUE (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients were administered with vaccines 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.   No concomitant product use was reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 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.  Vial was stored in cooler 1 on 03-APR-2021. On 03-APR-2021, Excursion time was 9 AM, temp was 34.Excursion duration at 8 am 38, at 9 am 34, at 10 am 38, at 11 am 42, at 12 pm 41, at 1 pm 41, at 2 pm 41, at 3 pm 40 and at 4 pm 40 and 5 pm 41 taken using a Fisher brand traceable temperature monitor in F  On 03-APR-2021, total doses given for the day was 210, condition of vaccine; prior to vaccination was not frozen, vaccine was moved to fridge on 30-MAR-2021, vial was moved to clinic on  03-APR-2021. 20 vials were moved to clinic. Vaccine BUD date was 29-APR-2021 for batch number 030B21A.  Vials were only punctured right before administration. Vaccines were not frozen at time of administration.Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic.  No treatment information was provided   This case was linked to MOD-2022-566976 (Patient Link).