Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients had been administered doses of the bivalent vaccine post excursion; No adverse event; There was a temperature excursion that occurred on 26-JAN-2023, the temperature went up to 8.4 C; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients had been administered doses of the bivalent vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (There was a temperature excursion that occurred on 26-JAN-2023, the temperature went up to 8.4 C) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     It was unknown whether patient ever been diagnosed with tested positive with COIVD-19. It was unknown patient had any acute illness or chronic health conditions at the time of vaccination.     On 26-Jan-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Jan-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was a temperature excursion that occurred on 26-JAN-2023, the temperature went up to 8.4 C). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients had been administered doses of the bivalent vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients had been administered doses of the bivalent vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (There was a temperature excursion that occurred on 26-JAN-2023, the temperature went up to 8.4 C) 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)) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Patients had been administered doses of the bivalent vaccine post excursion) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (There was a temperature excursion that occurred on 26-JAN-2023, the temperature went up to 8.4 C).    No concomitant medications were reported.  The impacted vials stored in the refrigerator. The refrigerator door was left open for 5 minutes and the temperature went up to 8.4C. This excursion wasn't caught until recently.   The reporter wanted to get a stability assessment for this excursion.   No patients had reported adverse reactions. The bivalent vaccine had been used from the start of the excursion until 24-Feb-2023. The adverse event involved the refrigerator door which  was open for 5 min and the temp rose to 8.4 degrees Celsius on 26-Jan-2023. The adverse event did not cause the patient to seek medical care. There was no other potential causes for the event to occur. Patient did not experienced a similar event in the past.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716571 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2023: Follow up information received and included Patient details added and Details about patient adverse events were updated in I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716571: