Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine had undergone a Temperature excursion the day before; No adverse event; The patient received Moderna Covid-19 vaccine that had undergone a Temperature excursion the day before; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine that had undergone a Temperature excursion the day before), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine had undergone a Temperature excursion the day before) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7172B and AS7165B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (001C21A expiration date December 13, 2021,Left arm) on 15-Apr-2021, MODERNA COVID-19 VACCINE (lot 005C21A expiration date December 22, 2021,left deltoid) on 13-May-2021, Moderna COVID-19 Vaccine (Lot number 051F21A expiration date is March 25, 2022,vaccine in his left deltoid) on 12-Nov-2021 and Moderna COVID-19 Vaccine (Lot number 051B22A Patient received in left deltoid) on 19-Jul-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 27-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, received sixth 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 27-Jun-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine that had undergone a Temperature excursion the day before). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine had undergone a Temperature excursion the day before) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine that had undergone a Temperature excursion the day before), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine had undergone a Temperature excursion the day before) 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 POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine that had undergone a Temperature excursion the day before) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine had undergone a Temperature excursion the day before).    No concomitant medication was reported.  No treatment information was reported.