Age: 67.0
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 67-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.  Storage condition at the time of the excursion was reported as frozen storage. Maximum or minimum temperatures reached was reported as 5.05 Degrees Fahrenheit (Excursion 1) 5.22 Degrees Fahrenheit (Excursion 2) 5.05 Degrees Fahrenheit (Excursion 3) 5.02 Degrees Fahrenheit (Excursion 4) 5.07 Degrees Fahrenheit (Excursion 5), 5.11 Degrees Fahrenheit (Excursion number 6) 5.05 degrees Fahrenheit (excursion number 7), 5.05 degrees Fahrenheit (Excursion 8) and 5.11 Degrees Fahrenheit (Excursion 9). Excursion duration was reported as 28 minutes (Excursion 1) 28 minutes (Excursion 2) 20 minutes (Excursion 3) 21 minutes (Excursion 4) 15 minutes (Excursion 5) 29 minutes (Excursion number 6), 13 minutes (Excursion number 7) and 34 minutes (Excursion 8). The Moderna Covid-19 vaccine was moved from the freezer to the refrigerator on 09-Aug-2022. It was stated that 1 vial was in the refrigerator under quarantine and up to 9 vials from the carton of Moderna Covid-19 vaccine had been administered to patients. Vaccines appeared normal after the excursion and were currently in the refrigerator. It was reported that there were several temperature excursions with these vial.  It was not known which dose in the series that the patient received vaccine that had undergone multiple temperature excursions. No other adverse reactions were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2022: Follow up received contains no new information.