Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient were administered with vaccine 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 were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021 at 4:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 4:47 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccine 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 58.51.  Concomitant products were not provided.  On 21-Mar-2021 vials were moved to clinic. On 16-Mar-2021 the vaccines were moved to fridge. 21-Mar-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 34, at 10 AM temperature was 32 and at 11 AM temperature was 34. The vaccine beyond use date was reported as 15-Apr-2021.  Vial was stored in cooler 1, on 21-Mar-2021, temperature excursion at 9 AM: 34, 10 AM: 32, 11 AM: 34, 12 PM: 43, 1PM: 40, 2 PM: 40, 3 PM: 41 and 4 PM: 41.  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 Fisherbrand 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.