Age: 70.0
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 a 70-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 10:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 11:02 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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, 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.33 at administration of 02-Mar-2021 and 70.41 at administration of 30-Mar-2021. Concomitant products were not provided. On 02-Mar-2021, at 09:00 A.M., the temperature recorded was 27 degree Fahrenheit, at 10:00 A.M, the temperature recorded was 29 degree Fahrenheit , at 11:00 A.M., the temperature recorded was 32 degree Fahrenheit, at 12:00 P.M., the temperature recorded was 33 degree Fahrenheit, at 02:00 P.M., the temperature recorded was 35 degree Fahrenheit, at 03:00 P.M., the temperature recorded was 36 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 02-Mar-2021.  On 30-Mar-2021 at 09:00 A.M., the temperature recorded was 33 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 30-Mar-2021   Vial was stored on cooler 1, on 02-Mar-2021, Excursion duration At 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM: 36, 2 PM : 35, 3 PM: 36, 4 PM: 37, 5PM: 37..  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 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 Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).