Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 1:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 4:31 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In April 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 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 61.04 for 2nd dose LOT 007C21A and 60.97 for 1st dose LOT 030B21A.  Concomitant medications were not provided.  On 03-Apr-2021 vials were moved to clinic. On 30-Mar-2021 the vaccines were moved to fridge. On 03-Apr-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 34.  The vaccine beyond use date was reported as 29-Apr-2021. Vial was stored in cooler 1, on 03-Apr-2021, temperature excursion at8 AM: 38,  9 AM: 34, 10 AM: 38, 11 AM: 42, 12 PM: 41 and 1PM: 41.Vial was stored in cooler 1, on 28-Apr-2021, temperature excursion at 9 AM: 33 and 10 AM: 36.  On 28-Apr-2021 vials were moved to clinic. On 19-Apr-2021 the vaccines were moved to fridge. On 28-Apr-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 33.  The vaccine beyond use date was reported as 19-May-2021. Vial was stored in cooler 1, on 28-Apr-2021, temperature excursion at 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 PM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41 and 4 PM: 40.  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.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).