Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 67-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 02-Mar-2021 at 12:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 11:58 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 PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) 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 27, At 10:00 AM temperature was 29, at 11 AM temperature was 32, at 12PM temperature was 33, at 2PM temperature was 35, at 3PM temperature was 36. Total 177 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 02-Mar-2021. 16 vials were moved to the clinic. Vaccine BUD date was 26-Mar-2021. The vaccine was administered on 02-Mar-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 9 am and the temperature was 33, total 173 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 30-Mar-2021. 3 vials were moved to the clinic. Vaccine BUD date was 22-Apr-2021. The vaccine was administered on 30-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.