Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administered vaccine dose from vial that undergone  temperature excursion from the day they received the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis. The patient had no known allergies. The patient was not ever diagnosed or tested with COVID. No medical history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination for each condition. The patient had not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered vaccine dose from vial that undergone temperature excursion from the day they received the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administered vaccine dose from vial that undergone  temperature excursion from the day they received the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (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 (administered vaccine dose from vial that undergone  temperature excursion from the day they received the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vial undergo temperature excursions). No concomitant medications was reported. The temperature excursion from the day they received the vaccine on the 24Jun2022 until 24Aug2022, because their freezer was not acceptable according to the local authority, they do not know a what temperature the vials were because they did not have DDT. They had administer 4 doses out of a 100 doses. The vial was stored at frozen storage at the time of the excursion. It was unknown, if the vial reached maximum or minimum temperatures. The vial was not moved from freezer to refrigerator. Not found any visual inspection any vaccine state change. 96 doses of vials or doses were impacted. No adverse event cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). No treatment drug details was reported.