Age: 89.0
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 89-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 28-Feb-2021 at 1:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:49 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 age of patient was provided as 89.49 at administration of 28-Feb-2021 and 89.57 at administration of 28-Mar-2021.  Concomitant products were not provided.  On 28-Feb-2021, at 09:00 A.M., the temperature recorded was 27 degree Fahrenheit, at 01:00 P.M, the temperature recorded was 26 degree Fahrenheit, and vial was initially moved to the fridge on 24-Feb-2021 and beyond use date was 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  On 28-Mar-2021, at 10:00 A.M., the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 23-Mar-2021 and beyond use date was 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was stored on cooler 1, on 28-Feb-2021, Excursion duration At 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM : 37, 3 PM: 43, 4 PM: 45.  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.  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.   This case was linked to MOD-2022-566976 (Patient Link).