Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion.; No adverse event; HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion.), POOR QUALITY PRODUCT ADMINISTERED (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion.) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 31-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-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 (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion.), POOR QUALITY PRODUCT ADMINISTERED (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion.) 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 (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion.) and POOR QUALITY PRODUCT ADMINISTERED (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion.).    No relevant concomitant medications were reported.  Ten doses of Moderna, go out of range (46.4 degrees) for 5 minutes on 31-May-2023.   HCP states that the excursion occurred on 31-May-2023 and the vaccine was administered to 4 patients post excursion.  HCP stated that the vials were stored in a cooler. They were thawed vials and were stored in the refrigerated temperature range in the cooler.  No treatment medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2023: Live follow-up information received included Drug(s) Information and Patient characteristics and Primary source(s) of information has been updated.