Age: 21.0
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 a 21-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 28-Feb-2021 at 10:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 10:23 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 (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 patient's age provided was 21.32.  Concomitant products not reported.  On 28 Feb 2021, Excursion time was 09 AM, 01 PM, temperature 27,26, total doses given for the day 152, condition of vaccine prior to administration not frozen, vaccine moved to fridge on 24 Feb 2021, vial moved to clinic on 27 Feb 2021. 20 vials were sent to clinic. Vaccine BUD was 26 Mar 2021. On 28 Mar 2021, Excursion time was 10 AM, temperature 35, total doses given for the day 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23 Mar 2021, vial was moved to clinic on 27 Mar 2021. 15 vials sent to clinic. Vaccine BUD was 22 Apr 2021. On 27 Feb 2021, vials stored in cooler 1, at following time and temperature respectively, 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. On 28 Feb 2021, vials stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43, 4 PM: 45. On 02 Mar 2021, vials stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM: 36, 2 PM: 35, 3 PM: 36, 4 PM: 37 and 5 PM: 37. On 03 Mar 2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM: 35, 2 PM: 36, 3 PM: 36, 4 PM: 36. The vials were punctured right before administration and all doses drawn from the vial due to high-pace clinic. Temperature recordings taken using Fisher brand traceable temperature monitor at every hour. Vaccine administered after more than 1 temperature excursion on 28 Feb 2021, 10.03 AM and on 28 Mar 2021, 10.23 AM. Then the vial was returned to the freezer or maintained at room temperature. 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, when the temperature data logger registered 34/35 degree F.  Treatment medications not reported.