Age: 34.0
Sex: F
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 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 9:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:54 AM, 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's age provided was 34.70. Concomitant products not provided. On 20 Mar 2021, Excursion time 09 AM, 10 AM, temperature 34, 37, total doses given for the day 184, condition of vaccine prior to administration not frozen, vaccine moved to fridge on 09 Mar 2021, vial moved to clinic on 20 Mar 2021.19 vials sent to clinic. Vaccine BUD 08 Apr 2021. On 13 Feb 2021, Excursion time 09 AM, temperature 32, total doses given for the day 152, condition of vaccine prior to administration not frozen, vaccine moved to fridge on 09 Feb 2021, vial moved to clinic on 13 Feb 2021.30 vials sent to clinic. Vaccine BUD 10 Mar 2021. On 20 Mar 2021 and 21 Mar 2021, vials stored in cooler 1, following time and temperature respectively, 9 AM: 34, 34, 10 AM: 30, 32, 11 AM: 41, 34, 12 AM: 45, 43, 1PM: 44, 40, 2 PM: 44, 40, 3 PM: 44, 41, 4 PM: 44, 41 and 5 PM: 43, 41. On 27 Mar 2021, vials stored in cooler 1, 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. On 28 Mar 2021, vials stored in cooler 1, following time and temperature respectively, 8 AM: 43, 9 AM: 38, 10 AM: 35, 11 AM: 44, 12 AM: 44, 1PM: 41, 2 PM: 46, 3 PM: 46, 4 PM: 42, 5 PM: 41. On 29 Mar 2021, vials stored in cooler 1, following time and temperature respectively, 9 AM: 38, 10 AM: 55, 11 AM: 44, 12 AM: 45, 1PM: 43, 2 PM: 40, 3 PM: 42, 4 PM: 43, 5 PM: 43. Vaccine administered after more than 1 temperature excursion on 13 Feb 2021, 09.52 AM and on 20 Mar 2021, 10.54 AM. The vials punctured right before administration and all doses drawn from vial due to high-pace clinic. Temperature recordings taken using Fisher brand traceable temperature monitor every hour. Then the vial returned to the freezer/maintained at room  temperature. The HCP explained that each time vial put into a cooler, there was a period of 1/1 and half hour approximately, when the temperature data logger registered 34/35 degree F.  Treatment medications not reported.   This case was linked to MOD-2022-566976 (Patient Link).