Age: 57.0
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 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 immunisation.     No Medical History information was reported.   On 27-Feb-2021 at 11:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 11:09 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.   No Concomitant product use was 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 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  For batch no. 014M20A, the excursion time on initial supply was 09 am, temperature was 33, At 10:00 AM temperature was 36, at 11 AM temperature was 35, at 12PM temperature was 35, at 1PM temperature was 35, at 2PM temperature was 35, at 3PM temperature was 34, at 4PM temperature was 34 and at 5PM temperature was 35. Total 199 doses were administered for that day, condition of vaccine prior to vaccination was not frozen. Vaccine moved to fridge on 24-Feb-2021 and moved to clinic on 27-Feb-2021. 20 vials were moved to the clinic. Vaccine BUD date was 26-Mar-2021. The vaccine was administered on 27-Feb-2021 and poor quality vaccine was administered, and the vaccine undergone product temperature excursion.  For batch no. 019B21A, the excursion time on initial supply was 9am & 10am and the temperature was 35 at both the time, total 195 doses were administered for that day, vaccine was not frozen prior to administration. Vaccine moved to fridge on 23-Mar-2021 and moved to clinic on 27-Mar-2021. 20 vials were moved to the clinic. Vaccine BUD date was 22-Apr-2021. The vaccine was administered on 27-Mar-2021 and poor quality vaccine was administered, and the vaccine undergone product temperature excursion.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.