Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Expired product administered, Immunisation reaction, Pyrexia
Clinical narrative: Dose administered after 30-day Use By Date/gave Moderna vaccine less than 12 hours after 30 day refrigeration expiration.; typical vaccine side effects; high fever; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (high fever), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/gave Moderna vaccine less than 12 hours after 30 day refrigeration expiration.) and IMMUNISATION REACTION (typical vaccine side effects) in a 38-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030337) for COVID-19 prophylaxis.     It was unknown whether patient ever been diagnosed with or tested positive for COVID-19. It was unknown whether patient had acute illness at the time of vaccination and up to one month before.  Previously administered products included for Product used for unknown indication: pfizer (ER8730, dose 1, Route and Body site: IM L Deltoid, 0.3 ml) on 23-Mar-2021, pfizer (ER8734, dose 2, Route & Body site: IM L Deltoid, 0.3 ml) on 13-Apr-2021, MODERNA COVID-19 VACCINE (025L21B and dose 3) on 14-Jun-2022. Past adverse reactions to the above products included Fever with pfizer and pfizer; and No adverse event with MODERNA COVID-19 VACCINE. Concurrent medical conditions included Hypertension (Managed with medication) since 19-Feb-2016 and Vitamin D deficiency. Concomitant products included AMLODIPINE from 17-Oct-2023 to an unknown date and HYDRALAZINE from 11-Oct-2023 to an unknown date for Hypertension, CHOLECALCIFEROL for Vitamin D deficiency, PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) from 13-Nov-2023 to an unknown date for an unknown indication.    On 26-Jan-2024 at 8:15 AM, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. In January 2024, the patient experienced PYREXIA (high fever) and IMMUNISATION REACTION (typical vaccine side effects). On 26-Jan-2024 at 8:15 AM,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/gave Moderna vaccine less than 12 hours after 30 day refrigeration expiration.). At the time of the report, PYREXIA (high fever), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/gave Moderna vaccine less than 12 hours after 30 day refrigeration expiration.) and IMMUNISATION REACTION (typical vaccine side effects) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105ºF.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The vial/PFS was initially stored in the refrigerator on 26-DEC-2023 or 27-DEC-2023. The vial/PFS did not undergo any temperature excursions. Gave Moderna vaccine less than 12 hours after 30-day refrigeration expiration. The vaccine was less than 12 hours expired, unopened, and was refrigerated.   Reported to clinic nurse typical vaccine side effects, though did have a high fever of 105ºF, which she stated has happened before when receiving Pfizer vaccines.   No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2024: Significant follow-up received contains reporter details, patient's demographic details, medical history, route of administration, anatomical location, concomitant drugs and event (high fever). Updated narrative accordingly.