Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: Extra dose administered; No adverse event; Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.), EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7173B and AS7164B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 25-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 25-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.), EXTRA DOSE ADMINISTERED (Extra dose administered) 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 (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.) and EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medication details was reported.  The patient received the Moderna monovalent vaccine dose 1 on 05-Mar-2021, dose as unknown, route of administration as unknown, lot number 036A21A. The patient received the Moderna monovalent vaccine dose 2 on 02-Apr-2021, dose as unknown, route of administration as unknown, lot number 028A21A. The patient received the Moderna booster vaccine on 07-Dec-2021, dose as 0.25 ml, route of administration as unknown, lot number 031H21A.  No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-726797 (Linked Report). This case was linked to MOD-2023-726988 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2023: Live Non-significant follow up information received. On 30-May-2023: Live Significant follow up information was received_Patient demography (initial, date of birth and age), Suspect product vaccine details (additional booster) and Narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726797:Patient 1