Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 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 male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021 at 10:44 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:19 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). 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). 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 the patient was reported as 68.60 and 68.67. No concomitant medications were reported. On 03-Mar-2021, 20 vials were moved to clinic. For the 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 51 degree Fahrenheit, at 10:00 AM the temperature recorded was 34 degree Fahrenheit and at 01:00 PM, the temperature recorded was 35 degree Fahrenheit that has been reached by the vial. The vial was moved to clinic on 03-Mar-2021. On 31-Mar-2021, 14 vials were moved to clinic. For the lot no. 030B21A, the vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021. On the date of administration, at 08:00 A.M, the temperature recorded was 32 degree Fahrenheit and at 09:00 AM, the temperature recorded was 32 degree Fahrenheit that has been reached by the vial. The vial was moved to clinic on 31-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 Fisherbrand 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).