Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received Moderna Covid-19 vaccine that had undergone multiple temperature excursions; Patients 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna Covid-19 vaccine that had undergone multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patients received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 61-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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna Covid-19 vaccine that had undergone multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patients received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna Covid-19 vaccine that had undergone multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patients 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Patients received Moderna Covid-19 vaccine that had undergone multiple temperature excursions).    Patient weight was unknown.  Concomitant medication list was not provided.  It was not known which dose in the series had the patient received, that had undergone multiple temperature excursions.  13 patients received Moderna COVID-19 vaccine that had undergone multiple temperature excursions.  Storage condition at the time of the excursion was frozen storage.  Maximum or minimum temperatures reached, as applicable were as follows, 5.05 Degrees Fahrenheit (Excursion 1), 5.22 Degrees F (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), 5.11 Degrees Fahrenheit (Excursion 9).  Excursion duration were as follows, 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), 34 minutes (Excursion 8).  The Moderna COVID-19 vaccine was moved from  the freezer to the refrigerator on 09-Aug-2022.  On visual inspection vaccines appeared normal after the excursion and were currently in the refrigerator.  9 vials were punctured after at least one temperature excursion. There were several temperature excursions with these vials. Now 1 Vial is in the refrigerator under quarantine and up to 9 vials from the carton of Moderna COVID-19 vaccine had been administered to patients.  No other adverse reactions were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2022: Live Follow up received contains no new significant information.