Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 83-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 27-Feb-2021 at 2:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 2:43 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine 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.   The age of patient was provided as 83.78.  Concomitant products were not provided.  On 27-feb-2021, vials were stored in cooler 1, at following time and temperature respectively,  8 AM: 35, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34  and 5 PM: 35. Total doses given for the day was 199 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9AM vaccine was moved to fridge on 24-Feb-2021 and 9 AM. Vial was moved to clinic on 27-feb-2021 vials were sent to clinic. Vaccine BUD date was 26-mar-2021 for 9 AM respectively. On 27-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively,  8 AM: 48, 9 AM: 35, 10 AM: 35, 11 AM: 38, 12 AM: 43, 1PM: 41, 2 PM: 41, 3 PM: 41, 4 PM: 40. Condition of vaccine prior to administration was not frozen. 9AM vaccine was moved to fridge on 30-Mar-2021. Vial was moved to clinic on 03-Apr2021 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021 for 9 AM respectively.  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 traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.