Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No adverse event; excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion. / 10 doses of Moderna, lot 02h22a, go out of range (46.4 degrees) for 5 minutes on 5/31/2023; 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.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion. / 10 doses of Moderna, lot 02h22a, go out of range (46.4 degrees) for 5 minutes on 5/31/2023), PRODUCT STORAGE ERROR (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.) 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 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, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion. / 10 doses of Moderna, lot 02h22a, go out of range (46.4 degrees) for 5 minutes on 5/31/2023) and PRODUCT STORAGE ERROR (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.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion. / 10 doses of Moderna, lot 02h22a, go out of range (46.4 degrees) for 5 minutes on 5/31/2023), PRODUCT STORAGE ERROR (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.) 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 (excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion. / 10 doses of Moderna, lot 02h22a, go out of range (46.4 degrees) for 5 minutes on 5/31/2023) and PRODUCT STORAGE ERROR (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 concomitant medication information was reported.  HCP stated that the excursion occurred on 31-MAY-2023 and the vaccine was administered to 4 patients post excursion. No adverse reactions had been reported by any patients. It was dose number 6 for all patients.  No treatment medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2023: Live Significant follow up information was appended_Additional reporter, Patient demography, Suspect product details (start date, expiry date, indication) was updated.