Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Mild flu like symptoms; Arm Soreness; Doses from temperature excursion were administered; Doses from temperature excursion were administered; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild flu like symptoms), PAIN IN EXTREMITY (Arm Soreness), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses from temperature excursion were administered) and POOR QUALITY PRODUCT ADMINISTERED (Doses from temperature excursion were administered) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination.     It was unknown that patient had ever been diagnosed with or tested positive for COVID-19. It was unknown that patient had any acute illness at the time of vaccination or a month before.  Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, GERD, Drug allergy (Quinine), Drug allergy (Sulfa), Drug allergy (codeine), Contrast media allergy and Drug allergy (Hydrocodone-APAP).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 09-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses from temperature excursion were administered). On 09-May-2022 at 9:30 AM, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses from temperature excursion were administered). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Mild flu like symptoms) and PAIN IN EXTREMITY (Arm Soreness). At the time of the report, INFLUENZA LIKE ILLNESS (Mild flu like symptoms), PAIN IN EXTREMITY (Arm Soreness), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses from temperature excursion were administered) and POOR QUALITY PRODUCT ADMINISTERED (Doses from temperature excursion were administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The reporter stated that the temperature excursion occurred on 09-May-2022 at 9:30 AM.   Storage condition at the time of the excursion was reported as refrigerated storage. Maximum 8.6 C and minimum 5.1C temperature were reached. Excursion duration was reported as 15 minutes.  Date vial(s) moved from freezer to refrigerator was unknown. Number of vials/doses impacted was unknown. Vials are now returned to and stored in refrigerator. Visual inspection noting any vaccine state change: No No previous excursion was reported.  It was reported that the patient only experienced mild flu like symptoms and arm soreness as expected.  Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2022: Follow up received. Case validity updated. Patient demographics, dose details, additional events and medical history were added.