Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes; No adverse event; patients were given expired vaccine on 30-Mar-2023; patient was administered the vaccine that had undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were given expired vaccine on 30-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes), POOR QUALITY PRODUCT ADMINISTERED (patient was administered the vaccine that had undergone temperature excursion) 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. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Mar-2023, 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 30-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were given expired vaccine on 30-Mar-2023) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered the vaccine that had undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were given expired vaccine on 30-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes), POOR QUALITY PRODUCT ADMINISTERED (patient was administered the vaccine that had undergone temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (patients were given expired vaccine on 30-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered the vaccine that had undergone temperature excursion).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The vial had undergone temperature excursions on 10-Feb-2023: 10.2 F for 1 hour and 11 minutes. The vial was initially stored in the refrigerator on 29-Mar-2023.   No treatment medications were reported.  This case contains information for the 1st of 2 adult patients who received the vaccine on 30-Mar-2023 described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-718070 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-718070:Master case-1st adult patient vaccine administer on 27Mar2023.