Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: The vaccine was involved in an excursion on 6/18/2023; No adverse event; The viability of expired Moderna that was administered to three patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The viability of expired Moderna that was administered to three patients), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was involved in an excursion on 6/18/2023) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 03-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The viability of expired Moderna that was administered to three patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was involved in an excursion on 6/18/2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The viability of expired Moderna that was administered to three patients), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was involved in an excursion on 6/18/2023) 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 NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The viability of expired Moderna that was administered to three patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was involved in an excursion on 6/18/2023).    Concomitant product use was not provided.  The reporter inquired about the viability of expired Moderna that was administered to three patients, and the validity of their vaccination.   The vaccine was involved in an excursion on 18-Jun-2023. Stored in the freezer. The temperature in the freezer went high reaching a maximum of 35.8°F for 11 hours and 39 minutes. Vaccine was not punctured.  Dose given was 0.5 ml/50 Microgram. From Punctured Vial.  Doses administered to patient one and two were from one vial and were administered past the published expiration date.   Dose administered to patient three was from another vial (same lot number) which underwent temperature excursion (refrigerator) and at the same time was past the manufacturer's expiration date.   The date the vial was initially stored in the freezer was 16-Jun-2023.  There were no doses administered from the vials which were stored in the freezer during the temperature excursion reported in the original case.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-731728, US-MODERNATX, INC.-MOD-2023-731716 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2023: Live follow-up information received included updated narrative. On 07-Jul-2023: Live follow-up information received included no new information. On 07-Jul-2023: Live follow-up information received included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731728: US-MODERNATX, INC.-MOD-2023-731716: