Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses 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 (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in an 80-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 02-Mar-2021 at 3:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:19 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses 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.   Concomitant products were not provided.  Patient age was reported as 80.74 and 80.81 years.  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. Vial was stored in cooler 1, on 02-Mar-2021, Excursion duration at 9 am 27, at 10 am  29, at 11 am 32, at 12 pm 33, at 1 pm  36, at 2 pm 35, at 3 pm 36 and at 4 pm 37 and 5 pm 37 taken using a Fisherbrand traceable temperature monitor in 014M20A. The excursion time on initial supply was  9A, 11A, 12P, 1P, 2P, to 3P,temperature was 27,29, 32,33 35 and 36 vaccine was not frozen prior to administration. Vaccine moved to fridge on 24-Feb-2021 and moved to clinic on 02-Mar-2021. 16 vials were sent to the clinic. BUD date was 26-Mar-2021 for batch number 014M20A. Vials only punctured right before administration. On 30-Mar-2021, Excursion at time 9 am was 33, using a Fisherbrand traceable temperature monitor. On 30-Mar-2021, total doses given for the day was 173, condition of vaccine; prior to vaccination was not frozen, vaccine was moved to fridge on 23-MAR-2021, vial was moved to clinic on 03-Mar -2021. 3 vials were moved to clinic. Vaccine BUD date was 22-APR-2021 for batch number 019B21A. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic No treatment information was provided Vaccine was stored in Cooler 1 on 28-Feb-2021. Treatment medications were not reported.