Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Maternal exposure during pregnancy, Product temperature excursion issue, SARS-CoV-2 test
Clinical narrative: Maternal exposure during pregnancy; Administered with vaccine that has been outside the refrigeration for more than 24 hours; temperature excursion; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that has been outside the refrigeration for more than 24 hours), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included COVID-19.   On 12-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Feb-2022 at 12:30 PM, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). On 15-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that has been outside the refrigeration for more than 24 hours). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 15-Feb-2022 at 4:30 AM, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) outcome was unknown. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that has been outside the refrigeration for more than 24 hours) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that  about 5.5ml vial that was left outside the refrigerator for more than 24hours (14Feb2022 at 12:30 to 15Feb2022 at 4:30pm) and administered to patient on 15Feb2022. Patient was fine and there is no show of any sign and symptoms.  Storage condition at the time of the excursion - Ambient temperature.  It was reported maximum or minimum temperatures reached (specified temp is in C or F)- 65 degrees Fahrenheit  Excursion duration was 24 hours  Vial(s) moved from freezer to refrigerator on 13Feb2022 at 4:00pm  Vial was Discarded  On Visual inspection noting any vaccine state change Vial was Thawed / in Liquid form  Proposed desired Use by Date - Vial used on 15Feb2022  Number of vials/doses impacted-1 (5.5ml)  It was reported vials were not punctured before the excursion  No concomitant and treatment medications were reported.