Age: 69.0
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 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 69-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 11:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 11:41 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced 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). 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 69.30 on 03-Mar-2021 and 69.37 on 31-Mar-2021.  No concomitant medications were reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  On 03-Mar-2021, batch number 014M20A, At excursion time of 9 AM, temperature was 51, at 10 AM temperature was 34 and at 1 PM temperature was 35. Total doses given for the day was 200, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 24-Feb-2021 and beyond use date was 26-Mar-2021. 20 vials were sent to clinic on 03-Mar-2021.  On 31-Mar-2021, batch number 030B21A, at excursion time of 9 AM temperature was 32., condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 30-Mar-2021 and beyond use date was 29-Apr-2021. 14 vials were sent to clinic on 31-Mar-2021.  Vial was stored on cooler 1, on 03-Mar-2021, Excursion duration At 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 PM: 46, 1 PM: 35, 2 PM : 36, 3 PM: 36 and 4 PM: 36 for batch number 014M20A.  Vial was stored on cooler 1, on 31-Mar-2021, Excursion duration At 8AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 PM: 43, 1 PM: 44, 2 PM : 46, 3 PM: 46, 4 PM: 44 and 5 PM: 44 for batch number 030B21A.  Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment information was provided.