Age: 71.0
Sex: M
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 a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021 at 3:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Oct-2021 at 1:25 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jan-2021 at 3:06 PM, 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, 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.   On 06-Jan-2021 Age of patient was reported as 71.61 and on 27-Oct-2021 Age of patient was reported as 72.41 No concomitant medications were reported. On 06-Jan-2021 at 03:00 P.M., the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 05-Jan-2021 and beyond use date was 27-Jan-2021. Product moved to clinic on 06-Jan-2021. Vial was stored on cooler 2, on 06-Jan-2021, Excursion duration At 11 AM: 41, 12 PM: 40, 1PM: 45, 2 PM : 45, 3 PM: 35, 4 PM: 44 and 5 PM : 44.  On 27-Oct-2021 at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit and vial was initially moved to the fridge on 29-Sep-2021 and beyond use date was 29-Oct-2021. Product moved to clinic on 27-Oct-2021, and at 10:00 Am the temperature recorded was 32 degree Fahrenheit and vial was initially moved to the fridge on 05-Oct-2021 and beyond use date was 04-Nov-2021. Product moved to clinic on 27-Oct-2021.  Vial was stored on cooler 1, on 27-Oct-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 PM: 43, 1PM: 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.