Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Poor quality product administered, Product temperature excursion issue, SARS-CoV-2 test
Clinical narrative: vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 hours; vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 hours/dose administered >12/24 hours post puncture; Patient received a second booster  and are not  immunocompromised or over 50 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 hours), POOR QUALITY PRODUCT ADMINISTERED (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 hours/dose administered >12/24 hours post puncture) and EXTRA DOSE ADMINISTERED (Patient received a second booster  and are not  immunocompromised or over 50 years of age) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     Patient did not had acute and chronic illnesses at the time of vaccination. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose #) no.  The patient's past medical history included COVID-19 on 11-Sep-2020. Previously administered products included for Drug use for unknown indication: JANSSEN COVID-19 VACCINE (Booster dose) and JANSSEN COVID-19 VACCINE (Primary series). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE and JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Drug allergy (Accutane allergy).    On 03-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 hours/dose administered >12/24 hours post puncture) and EXTRA DOSE ADMINISTERED (Patient received a second booster  and are not  immunocompromised or over 50 years of age). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 hours). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 hours), POOR QUALITY PRODUCT ADMINISTERED (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 hours/dose administered >12/24 hours post puncture) and EXTRA DOSE ADMINISTERED (Patient received a second booster  and are not  immunocompromised or over 50 years of age) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Date the vial was initially stored in the refrigerator: 29-Apr-2022.  On 29-Apr-2022 at 8:00 AM vial was first punctured. The vial was stored in fridge post puncture. Vial was moved from freezer to refrigerator.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):3 hours.  Maximum or minimum temperatures reached, as applicable (specify temp is in C or F) were not known and duration was 3 hours.  Storage condition at the time of the excursion was refrigerated storage.   Visual inspection noting any vaccine state change: (e.g. were frozen vials thawed, were thawed vials re-frozen, were they visualized at all) no.  Any previous excursions with the impacted vial was reported as no.  It was stated that, event did not cause patient to seek medical care.  There were no other potential causes and patient did not experience similar event in the past.  Treatment medications were not provided.