Age: 68.0
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 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 3:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 3:21 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Nov-2021 at 2:10 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, 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 68.87 on 03-Nov-2021, 68.28 on 31-Mar-2021 and 68.20 on 03-Mar-2021.  No concomitant medications were reported.  On 03-Nov-2021, excursion time was 10 AM, temperature was 35. Total doses given for the day was 117, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 05-Oct-2021 and beyond use date was 05-Nov-2021. 6 vials were sent to clinic on 03-Nov-2021.  On 31-Mar-2021, excursion time was 8 AM and 10 AM, temperature was 32. Total doses given for the day was 199, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 30-Mar-2021 and beyond use date was 29-Apr-2021.14 vials were sent to clinic on 31-Mar-2021.  On 03-Mar-2021, excursion time was 9 AM, 10 AM and 1 PM, temperature was 51, 34 and 37. Total doses given for the day was 200, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 24-Mar-2021 and beyond use date was 26-Mar-2021. 20 vials were sent to clinic on 03-Mar-2021.  Vial was stored on cooler 1, on 31-Mar-2021, Excursion duration At 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 PM: 43, 1 PM: 44, 2 PM : 46, 3 PM: 46, 4 PM: 44 and 5 PM: 44.  Vial was stored on cooler 1, on 03-Mar-2021, Excursion duration At 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 PM: 46, 1 PM: 35, 2 PM : 36, 3 PM: 36, 4 PM: 36 and 5 PM: 36.  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 34 or 35