Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5 F. A second excursion happened a couple hours later during 15 minutes and maximum temperature reached was 9.3 F; No adverse event; total of 13 doses were administered after the excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5°F. A second excursion happened a couple hours later during 15 minutes and maximum temperature reached was 9.3°F), POOR QUALITY PRODUCT ADMINISTERED (total of 13 doses were administered after the excursion happened) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     It was unknown if patient had relevant medical history, allergy, concomitant diseases and risk factor. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 12-May-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 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (total of 13 doses were administered after the excursion happened). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5°F. A second excursion happened a couple hours later during 15 minutes and maximum temperature reached was 9.3°F) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5°F. A second excursion happened a couple hours later during 15 minutes and maximum temperature reached was 9.3°F), POOR QUALITY PRODUCT ADMINISTERED (total of 13 doses were administered after the excursion happened) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5°F. A second excursion happened a couple hours later during 15 minutes and maximum temperature reached was 9.3°F) and POOR QUALITY PRODUCT ADMINISTERED (total of 13 doses were administered after the excursion happened).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that second excursion happened a couple hours later during 15 minutes and maximum temperature reached was 9.3°F. No other adverse events were reported. No treatment information was provided.  This case contains information about patient 4th out of 13 patients.   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728417:Patient 4