Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F; Dose administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F) in a 63-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 1:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 1:46 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Mar-2021 at 1:37 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were 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.  For batch  014M20A, vial was stored in cooler 1, on 02-Mar-2021, Excursion duration at 9 am: 27, at 10 am 29, at 11 am 32, at 12 am 33, at 1 pm 36, at 2 pm 35, at 3 pm 36, at 4 pm 37 and at 5 pm 37 taken using a Fisherbrand traceable temperature monitor in degree F.   On 02-Mar-2021, 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 for batch number 014M20A.  For batch number 019B21A, on 30-Mar-2021, total doses given for the day were 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 date was 22-Apr-2021.   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).