Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 81-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 27-Feb-2021 at 10:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 10:37 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Feb-2021 at 10:20 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 81.82 for date of administration on 27-Feb-2021 and 81.89 years for date of administration on 27-Mar-2021.  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 on cooler 1, on 27-Feb-2021, Excursion duration at 9 am: 33, at 10 am 36, at 11 am 35, at 12 am 35, at 1 pm 35, at 2 pm 35, at 3 pm 34, at 4 pm 34 and at 5 pm 435.  On 27-Feb-2021, excursion time and temperature at 09, 11 am, 12, 1, 2,3, 4, 5 pm was 33, 35, 35, 35, 35, 34, 34, 35 respectively total doses given for the day was 199, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vial was moved to clinic. Vaccine BUD date was 26-Mar-2021.  On 27-Mar-2021, excursion time and temperature at 09, 10 am was 35, 35 respectively total doses given for the day was 195, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021.  Vials only punctured right before administration.  Temperature recordings were taken by using a traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).