Age: 76.0
Sex: F
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 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 9:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 10:09 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Mar-2021 at 10:09 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.        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  for first regimen was 26-MAR-2021.  Vial  for first regimen  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 vials were moved to clinic.   Vaccine BUD  for second regimen was 22-APR-2021.  Vial  for first regimen was stored on cooler 1 , on 30-Mar-2021, Excursion duration 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.   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.   This case was linked to MOD-2022-566976 (Patient Link).