Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Underdose
Clinical narrative: Vaccine was out of range/Vaccine administered after the temperature excursion occured from 22-Aug-2022 to 04-Sep-2022; No adverse event; Administered 3 doses that experienced the excursions; Patient received 0.25 ml as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine was out of range/Vaccine administered after the temperature excursion occured from 22-Aug-2022 to 04-Sep-2022), POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions), UNDERDOSE (Patient received 0.25 ml as a first dose) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2022 at 7:30 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 24-Aug-2022 at 7:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions) and UNDERDOSE (Patient received 0.25 ml as a first dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine was out of range/Vaccine administered after the temperature excursion occured from 22-Aug-2022 to 04-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine was out of range/Vaccine administered after the temperature excursion occured from 22-Aug-2022 to 04-Sep-2022), POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions), UNDERDOSE (Patient received 0.25 ml as a first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine was out of range/Vaccine administered after the temperature excursion occured from 22-Aug-2022 to 04-Sep-2022), POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions) and UNDERDOSE (Patient received 0.25 ml as a first dose).    No concomitant medications were reported. Vaccine was stored in fridge at the time of excursion. The maximum temperature reached was 52.8 Fahrenheit and the excursion duration was 8 days, 16 hours and 30 minutes. on 22-Aug-2022 the vial was moved from freezer to refrigerator and vaccine was stored in fridge as of now. Total 3 doses was impacted from the vial. A total of 3 doses were administered with no previous excursions. On 05-Sep-2022 fridge was died and ever since the fridge went out of range that past weekend and no doses was administered. The temperature went up to 70 degree and the vaccine in that fridge were moved to another fridge. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2022: Follow up information received contains no new information.