Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: 2 Adult Patients received the Bivalent booster vaccine after excursion on 08SEP2022, and 10OCT2022; 2 Adult Patients received the Bivalent booster vaccine after excursion on 08SEP2022, and 10OCT2022; Product storage error; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (2 Adult Patients received the Bivalent booster vaccine after excursion on 08SEP2022, and 10OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (2 Adult Patients received the Bivalent booster vaccine after excursion on 08SEP2022, and 10OCT2022), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in an adult 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. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (2 Adult Patients received the Bivalent booster vaccine after excursion on 08SEP2022, and 10OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (2 Adult Patients received the Bivalent booster vaccine after excursion on 08SEP2022, and 10OCT2022), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (2 Adult Patients received the Bivalent booster vaccine after excursion on 08SEP2022, and 10OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (2 Adult Patients received the Bivalent booster vaccine after excursion on 08SEP2022, and 10OCT2022), PRODUCT STORAGE ERROR (Product storage error) 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 (2 Adult Patients received the Bivalent booster vaccine after excursion on 08SEP2022, and 10OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (2 Adult Patients received the Bivalent booster vaccine after excursion on 08SEP2022, and 10OCT2022) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were provided by the reporter.  It was reported that 2 adult patients received the Bivalent booster vaccine after excursion on 08SEP2022, and 10OCT2022. The facility could not move the vaccine to the refrigerator because there was no data logger in the refrigerator.Bivalent Adult Lot number and Expiration Date was provided lot number as 074B22Aand expiry date as 11DEC2022 and lot number 057S22A and expiry date as 11MAY2023.  Maximum or minimum temperatures reached on 19SEP2022 10:15AM to 10:45AM 30 Min Max -12.92C & Min -18.23C 05SEP2022 21:30 to 08SEP2022 at 6:45AM DDL has no temperature recording on 08SEP2022 at 7AM temperature reading was -23.07 C Excursion duration was 19SEP2022 Duration: 30 Minutes 05SEP2022 21:30 to 08SEP2022 at 6:45AM Duration was 57 hours date vials moved from freezer to refrigerator. The vial undergo any temperature excursions on 19SEP2022 10:15AM to 10:45AM 30 Min Max -12.92C & Min -18.23C 05SEP2022 21:30 to 08SEP2022 at 6:45AM DDL has no temperature recording on 08SEP2022.  No treatment medications were provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689438.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689438:original case 2 out 2 cases