Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: a patient potentially received a dose from a vial that underwent a temperature excursion; they had a temperature excursion where vials reached 48 degrees Fahrenheit starting at 11pm on 03May2022 and the excursion has remained for 36hours (at time of call on 05052022).; they had a temperature excursion where vials reached 48 degrees Fahrenheit starting at 11pm on 03May2022 and the excursion has remained for 36hours (at time of call on 05052022).; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (a patient potentially received a dose from a vial that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (they had a temperature excursion where vials reached 48 degrees Fahrenheit starting at 11pm on 03May2022 and the excursion has remained for 36hours (at time of call on 05052022).) and PRODUCT STORAGE ERROR (they had a temperature excursion where vials reached 48 degrees Fahrenheit starting at 11pm on 03May2022 and the excursion has remained for 36hours (at time of call on 05052022).) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (a patient potentially received a dose from a vial that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (they had a temperature excursion where vials reached 48 degrees Fahrenheit starting at 11pm on 03May2022 and the excursion has remained for 36hours (at time of call on 05052022).) and PRODUCT STORAGE ERROR (they had a temperature excursion where vials reached 48 degrees Fahrenheit starting at 11pm on 03May2022 and the excursion has remained for 36hours (at time of call on 05052022).). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (a patient potentially received a dose from a vial that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (they had a temperature excursion where vials reached 48 degrees Fahrenheit starting at 11pm on 03May2022 and the excursion has remained for 36hours (at time of call on 05052022).) and PRODUCT STORAGE ERROR (they had a temperature excursion where vials reached 48 degrees Fahrenheit starting at 11pm on 03May2022 and the excursion has remained for 36hours (at time of call on 05052022).) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The Pharmacist stated that, on 03-May-2022 starting at 11 pm, they had a temperature excursion where vials reached 48 degrees Fahrenheit and the excursion has remained for 36 hours (05May2022).Initially stated the a dose from the vial was administered 05May2022 and then later stated that the patient was given a dose of vaccine from the vial on 04May2022 in the morning. Ultimately, it was not sure of exact date of administration. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow-up document received contains no new information.