Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Poor quality product administered, 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; Temperature excursion on 05-Nov-2022 at 44.86 degree fahrenheit for 15 min and administered on 07-Nov-2022; 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 POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion on 05-Nov-2022 at 44.86 degree fahrenheit for 15 min and administered on 07-Nov-2022), 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 patient of an unknown age and 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 POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion on 05-Nov-2022 at 44.86 degree fahrenheit for 15 min and administered on 07-Nov-2022) and 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, POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion on 05-Nov-2022 at 44.86 degree fahrenheit for 15 min and administered on 07-Nov-2022), 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 POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion on 05-Nov-2022 at 44.86 degree fahrenheit for 15 min and administered on 07-Nov-2022), 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).    Patient date of birth was reported. 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  was 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 US-MODERNATX, INC.-MOD-2022-679887 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Follow-up received contains: Additional event expired vaccine used was added along with all the relevant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679887:same reporter