Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 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 during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 2:14 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 2:16 PM, received second 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 during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 27.70 years on 28 Feb 2021 and 27.78 years on 28 Mar 2021. Concomitant products were not provided.  On 28 Mar 2021, at excursion time of 10 AM, temperature was 35, total doses given for the day was 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 were sent to clinic. Vaccine BUD date was 22 Apr 2021 (019B21A). On 28 Feb 2021, (014M20A), at excursion time of 9 AM temperature was 27, at excursion time of 1 PM temperature was 26, total doses given for the day was 152. Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24 Feb 2021, vial was moved to clinic on 27 Feb 2021. 20 vials were sent to clinic. Vaccine BUD date was 26 Mar 2021.  On 28 Feb 2021, vials were stored in cooler 1, at following time and temperature, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 PM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45.  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.  Vials were held in a fridge until the day of clinic and then held in a cooler when excursions were experienced.  On 28 Feb 2021 (014M20A) underwent an accidental refreeze, first excursion 27F, back in range and second excursion was at 26F for two hours. Vial underwent a second excursion.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2022: Follow-up received contains Reporter information added. On 23-May-2022: Significant Follow-up received contains Expiry date updated. On 23-May-2022: Significant Follow-up received contains narrative updated