Age: 65.0
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 65-year-old male 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 1:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 1:28 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. 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) and POOR QUALITY PRODUCT ADMINISTERED (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 age of the patient was reported as 65.42 and 65.50.   No concomitant medications were reported.  On 27-Feb-2021, 20 vials were moved to clinic. For lot no. 014M20A, the vial was initially moved to the fridge on 24-Feb-2021 and proposed beyond use date was 26-Mar-2021. On the date of administration, at 09:00 A.M., the temperature recorded was 33 degree Fahrenheit, at 11:00 A.M to 02:00 PM., the temperature recorded was 35 degree Fahrenheit, at 12:00 PM., the temperature recorded was 34 degree Fahrenheit and at 05:00 PM, the temperature recorded was 35 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 27-Feb-2021.  On 27-Mar-2021, 20 vials were moved to clinic. For lot no. 019B21A, the vial was initially moved to the fridge on 23-Mar-2021 and proposed beyond use date was 22-Apr-2021. On the date of administration, at 09:00 A.M., the temperature recorded was 35 degree Fahrenheit and at 10:00 A.M the temperature recorded was 35 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 27-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.  This case was linked to MOD-2022-566976 (Patient Link).