Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022; Temperature excursion on 05-Nov-2022 at 44.86 degree fahrenheit for 15 min and administered on 07-Nov-2022; No adverse event; Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022/ 6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022/ 6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired), PRODUCT STORAGE ERROR (Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion on 05-Nov-2022 at 44.86 degree fahrenheit for 15 min and administered on 07-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 49-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022/ 6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion on 05-Nov-2022 at 44.86 degree fahrenheit for 15 min and administered on 07-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022/ 6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired), PRODUCT STORAGE ERROR (Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion on 05-Nov-2022 at 44.86 degree fahrenheit for 15 min and administered on 07-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022/ 6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after vaccine was expired), PRODUCT STORAGE ERROR (Vaccine was moved from freezer to refrigerator on 03-Oct-2022 and administered on 07-Nov-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion on 05-Nov-2022 at 44.86 degree fahrenheit for 15 min and administered on 07-Nov-2022).    Concomitant product use was not provided by the reporter.  It was reported that storage condition at the time of excursion was refrigerated storage. Total 7 vials were involved and vial size was 2.5 ml. Visual is inspection of vaccine was thawed with no visual changes. On 07-Nov-2022, total 6 doses of Moderna Covid-19 Vaccine, Bivalent were administered after multiple temperature excursions and after vaccine was expired.  Other temperature excursion occurred on 08-Nov-2022 at 35.88 degree Fahrenheit for 15 minute, on 09-Nov-2022 at 34.62 degree Fahrenheit for 15 minute and on the same at 3:37 P.M at 35.15 degree Fahrenheit for 15 minute.  Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2022-679887 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Live follow up information received on 29-Nov-2022. Event added. Case narrative was updated.; Sender's Comments:  MODERNATX, INC.-MOD-2022-679887:Same reporter