Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: vial was initially stored in refrigerator on 8Sep2022 and administered on 9Oct to 21Oct2022; No adverse event; Dose administered after 30-day Use By Date; Minimum temperature: 29.25 degrees F Maximum 35.9 degrees F ,Cumulative estimated time duration: 15 minutes ,The vaccines reached a Min 29.2 degrees F with small excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 8Sep2022 and administered on 9Oct to 21Oct2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Minimum temperature: 29.25 degrees F Maximum 35.9 degrees F ,Cumulative estimated time duration: 15 minutes ,The vaccines reached a Min 29.2 degrees F with small excursions) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, 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. In October 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT TEMPERATURE EXCURSION ISSUE (Minimum temperature: 29.25 degrees F Maximum 35.9 degrees F ,Cumulative estimated time duration: 15 minutes ,The vaccines reached a Min 29.2 degrees F with small excursions). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 8Sep2022 and administered on 9Oct to 21Oct2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 8Sep2022 and administered on 9Oct to 21Oct2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Minimum temperature: 29.25 degrees F Maximum 35.9 degrees F ,Cumulative estimated time duration: 15 minutes ,The vaccines reached a Min 29.2 degrees F with small excursions) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 8Sep2022 and administered on 9Oct to 21Oct2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Minimum temperature: 29.25 degrees F Maximum 35.9 degrees F ,Cumulative estimated time duration: 15 minutes ,The vaccines reached a Min 29.2 degrees F with small excursions).    No concomitant medications were reported.  The vials were stored in refrigerator. Total 10 vials were there. Vial size was 2.5mL. The minimum temperature 29.25 degrees F and maximum was 35.9 degrees F. Reporter said the excursion was very small and lasted for only a couple of seconds each time over the period of October. Cumulative estimated time duration was 15 minutes. The vial was moved from  freezer to refrigerator on 08-Sep-2022. The vials are now stored in refrigerator. The vial seemed pretty good during visual inspection. The vial were no longer being used. The vial underwent temperature excursion before but they did not report them. The vaccines reached a Min 29.2 degrees F with small excursions but did not have the duration. The vaccines were administered from 09-Oct-2022 until 21-Oct-2022. It was reported that only 3 patients were administered after the expiry date instead of 87  but  only 3 patients were administered after the expiry date. Expired vaccines were administered in between 09-Oct-2022 and 21-Oct-2022. No treatment medications were reported.  The case became invalid on 7Nov2022, as the case was reported for multiple adult male patients without patient specific details.   This case was linked to US-MODERNATX, INC.-MOD-2022-668664 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2022: Follow-up received and contains patient gender, updated number of patients and added administration dates.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668664:same reporter