Age: 56.0
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 56-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 03-Mar-2021 at 9:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:51 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Mar-2021 at 9:51 AM, 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 56.42 and 56.50. No concomitant medications were reported. On 02-Mar-2021, 16 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 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 and at 03:00 P.M., the temperature recorded was 36 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 02-Mar-2021. On 30-Mar-2021, 3 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 33 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 30-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. Occupation of reporter was reported as clinic manager. This case was linked to MOD-2022-566976 (Patient Link).