Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion; It was reported that unknown number of patients were 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 81-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 10:32 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:51 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 (It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (It was reported that unknown number of patients were 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 81.64  No concomitant medication was reported.  On 24-Feb-2021,vaccine (014M20A) moved to fridge and vaccine BUD date was reported as 26-Mar-2021. Condition of vaccine prior to administration was reported Not frozen.  On 27-Feb-2021,vaccine excursion time were 9am,11am,12pm,1pm,2pm,3pm,4pm,5pm at 33,35,35,35,35,34,34,35 degree F temperature. On 28-Feb-2021,vaccine excursion time was 9am,1pm at 27,26 degree F temperature. On 2-Mar-2021,vaccine excursion time were 9am,10am,11am,12pm, 2pm,3pm at 27,29,32,33,35,36 degree F temperature. On 3-Mar-2021,vaccine excursion time were 9am,10am,1pm at 51,34,35 degree F temperature and vaccine got moved to clinic.  On 30-Mar-2021,vaccine (030B21A) moved to fridge and vaccine BUD date was reported as 29-Apr-2021. Condition of vaccine prior to administration was reported Not frozen.   On 31-Mar-2021,vaccine excursion time at 9am was 32 degree F temperature and vaccine got moved to clinic. On 3-Apr-2021,vaccine excursion time was 9am at 34 degree F temperature.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 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.  Treatment medications were not reported.