Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna COVID-19 vaccine that had undergone multiple temperature excursions.; Patient received Moderna COVID-19 vaccine that had undergone multiple temperature excursions.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna COVID-19 vaccine that had undergone multiple temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna COVID-19 vaccine that had undergone multiple temperature excursions.) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna COVID-19 vaccine that had undergone multiple temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna COVID-19 vaccine that had undergone multiple temperature excursions.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna COVID-19 vaccine that had undergone multiple temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna COVID-19 vaccine that had undergone multiple temperature excursions.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (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 (Patient received Moderna COVID-19 vaccine that had undergone multiple temperature excursions.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna COVID-19 vaccine that had undergone multiple temperature excursions.).    Patient weight was unknown. No concomitant medications were reported. The pharmacist reported that, the vaccine underwent multiple temperature excursion and the storage condition at the time of temperature excursion was frozen.  The maximum or minimum temperatures reached were first excursion at 5.05 Degrees F (Fahrenheit)  for 28 minutes, second excursion at 5.22 Degrees F for 28 minutes, third excursion at 5.05 Degrees F for 20 minutes, forth excursion at 5.02 Degrees F for 21 minutes, fifth excursion at 5.07 Degrees F for 15 minutes, sixth excursion at 5.11 Degrees F for 29 minutes, seventh excursion at 5.05 degrees F for 13 minutes, eighth excursion at 5.05 degrees F for 34 minutes and ninth excursion at 5.11 Degrees F for unspecified time.  On 09-Aug-2022, the vials were initially moved from freezer to refrigerator and vials were in the refrigerator under quarantine currently. Upon visual inspection vaccines appeared normal after the excursion. It was reported that up to 9 vials from the carton of Moderna COVID-19 vaccine had been administered to patients and it was not known which dose in the series that the patient received vaccine had undergone multiple temperature excursions.  No other adverse reactions were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2022: Follow-up document received includes no new information.