Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vials might have been exposed to a temperature excursion/ Patient received a possibly affected dose; No adverse event; Vials might have been exposed to a temperature excursion/ Patient received a possibly affected dose; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vials might have been exposed to a temperature excursion/ Patient received a possibly affected dose), PRODUCT TEMPERATURE EXCURSION ISSUE (Vials might have been exposed to a temperature excursion/ Patient received a possibly affected dose) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Covid-19 vaccine (Dose 1), Covid-19 vaccine (Dose 3) and Covid-19 vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Covid-19 vaccine, Covid-19 vaccine and Covid-19 vaccine.    On 16-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vials might have been exposed to a temperature excursion/ Patient received a possibly affected dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vials might have been exposed to a temperature excursion/ Patient received a possibly affected dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vials might have been exposed to a temperature excursion/ Patient received a possibly affected dose), PRODUCT TEMPERATURE EXCURSION ISSUE (Vials might have been exposed to a temperature excursion/ Patient received a possibly affected dose) 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 (Vials might have been exposed to a temperature excursion/ Patient received a possibly affected dose) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials might have been exposed to a temperature excursion/ Patient received a possibly affected dose).    Concomitant product use was not provided by the reporter.  It was reported that experienced a malfunction in a secondary temperature recording device health care professional wouldn't be able to determine if a temperature excursion took place at the time of the call freezer had a unit that would trigger an alarm if a temperature excursion happened which health care professional would be checking it later Vials might had been exposed to a temperature excursion but health care professional would not be able to tell. one Patient received a possibly affected dose patient received in the past 3 doses of COVID19 vaccines.  Treatment information was not provided.