Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: A patient received Moderna Covid-19 vaccine was left out at room temperature for more than 24 hours.; No adverse event; A patient received Moderna Covid-19 vaccine after it had been punctured more than 12 hours ago a/Patient received Booster dose from a vial exposed to room temperature more than 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received Moderna Covid-19 vaccine after it had been punctured more than 12 hours ago a/Patient received Booster dose from a vial exposed to room temperature more than 24 hours), PRODUCT STORAGE ERROR (A patient received Moderna Covid-19 vaccine was left out at room temperature for more than 24 hours.) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2022 at 3:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2022 at 3:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received Moderna Covid-19 vaccine after it had been punctured more than 12 hours ago a/Patient received Booster dose from a vial exposed to room temperature more than 24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (A patient received Moderna Covid-19 vaccine was left out at room temperature for more than 24 hours.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received Moderna Covid-19 vaccine after it had been punctured more than 12 hours ago a/Patient received Booster dose from a vial exposed to room temperature more than 24 hours), PRODUCT STORAGE ERROR (A patient received Moderna Covid-19 vaccine was left out at room temperature for more than 24 hours.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (A patient received Moderna Covid-19 vaccine after it had been punctured more than 12 hours ago a/Patient received Booster dose from a vial exposed to room temperature more than 24 hours) and PRODUCT STORAGE ERROR (A patient received Moderna Covid-19 vaccine was left out at room temperature for more than 24 hours.).    No concomitant medication were provided  It was reported that patient received Booster dose from a vial exposed to room temperature more than 24 hours.   It was reported that 1 vial was initially stored in the refrigerator on 18 Aug 2022 at 7:00 AM.  Vial did not undergone any temperature excursion. The total amount of time the vial was exposed to room temperature was 8 degree to 25 degree Celsius equal to   46 to 77 degree Fahrenheit was for 31 hours   No treatment details were provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Follow up received included significant information patient details and product details were added On 08-Sep-2022: Follow up received included non significant information.