Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Expired product administered, Fatigue, Pyrexia
Clinical narrative: Vaccine had been expired for about 48 hours at the time that she got / 12 year old patient was administered a dose of the Spikevax 2023-2024 vaccine from a vial that was past the 30 day beyond use date; Patient had 24 hrs of fatigue; Tmax 100.5 fever; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Patient had 24 hrs of fatigue), PYREXIA (Tmax 100.5 fever) and EXPIRED PRODUCT ADMINISTERED (Vaccine had been expired for about 48 hours at the time that she got / 12 year old patient was administered a dose of the Spikevax 2023-2024 vaccine from a vial that was past the 30 day beyond use date) in a 12-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1), PFIZER BIONTECH COVID-19 VACCINE (Dose 3) and PFIZER BIONTECH COVID-19 VACCINE (Dose 2). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included ADHD (No recent changes in condition), Anxiety (No recent changes in condition), Rhinitis and Insomnia. Concomitant products included GUANFACINE HYDROCHLORIDE (INTUNIV) for ADHD, FLUOXETINE HYDROCHLORIDE (PROZAC) and LAMOTRIGINE (LAMICTAL) for Anxiety, MELATONIN for Insomnia, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Rhinitis, INFLUENZA VACCINE for an unknown indication.    On 27-Nov-2023 at 3:00 PM, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. In 2023, the patient experienced FATIGUE (Patient had 24 hrs of fatigue) and PYREXIA (Tmax 100.5 fever). On 27-Nov-2023 at 3:00 PM,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had been expired for about 48 hours at the time that she got / 12 year old patient was administered a dose of the Spikevax 2023-2024 vaccine from a vial that was past the 30 day beyond use date). In 2023, FATIGUE (Patient had 24 hrs of fatigue) and PYREXIA (Tmax 100.5 fever) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine had been expired for about 48 hours at the time that she got / 12 year old patient was administered a dose of the Spikevax 2023-2024 vaccine from a vial that was past the 30 day beyond use date) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Body temperature: 100.5.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   It was reported that the patient was getting the Moderna booster dose after getting three doses of Pfizer vaccine prior to this. The Moderna booster dose that she got apparently had been expired for about 48 hours at the time that she got the vaccine.  HCP stated that a 12-year-old patient was administered a dose of the Spikevax 2023-2024 vaccine from a vial that was past the 30 days beyond use date.  She was doing well upon check up on 05-Dec-2023. Moderna analysis showed lot number maintained activity at 32 day refrigerated date. There were no other potential cause reported and the patient haven't had similar event in past.  Patient received Spikevax vaccine 48 hours past the use by date for refrigerated storage. Patient also received annual flu vaccine. Patient had 24 hours of fatigue and fever but had no other adverse side effects till date. No re-dose was given to patient or recommended to the patient's family.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2023: Significant follow up information received included : Patient demographics updated, medical history updated, lab data added, concomitant drugs added and events (fatigue and fever) were added.