Age: 70.0
Sex: F
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female 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 3:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 3:59 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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.   Concomitant products were not provided.  It was reported that unknown number of patients were 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 time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  For batch no. 019B21A, The excursion time on initial supply was 10am, temperature was 35, total 150 doses were administered for that day, vaccine was not frozen prior to administration. Vaccine moved to fridge on 23-Mar-2021 and moved to clinic on 27-Mar-2021. 15 vials were sent to the clinic. BUD date was 22-Apr-2021. Vials only punctured right before administration.  For batch no. 014M20A, The excursion time on initial supply was 09 am, temperature was 27 and total 152 doses were administered for that day. At 01 pm, temperature was 26. Vaccine was not frozen prior to administration. Vaccine moved to fridge on 24-Feb-2021 and moved to clinic on 27-Feb-2021. 20 vials were sent to the clinic. BUD date was 26-Mar-2021. Vials only punctured right before administration.  For batch no. 014M20A, Vial was stored on cooler 1, on 28-Oct-2021, Excursion duration At 9 AM: 27, 9 AM: 32 and 01 PM: 26.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).