Age: 34.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Injection site pain
Clinical narrative: Flu like symptoms included: generalized body aches, shivers, sweating; Muscle Pain at injection site; they accidentally administered 2 doses of Spikevax of 0.5 ml each to an adult patient; they accidentally administered 2 doses of Spikevax of 0.5 ml each to an adult patient; Brain fog; This spontaneous case was reported by a pharmacist and describes the occurrence of BRAIN FOG (Brain fog), INFLUENZA LIKE ILLNESS (Flu like symptoms included: generalized body aches, shivers, sweating), INJECTION SITE PAIN (Muscle Pain at injection site), EXTRA DOSE ADMINISTERED (they accidentally administered 2 doses of Spikevax of 0.5 ml each to an adult patient) and ACCIDENTAL OVERDOSE (they accidentally administered 2 doses of Spikevax of 0.5 ml each to an adult patient) in a 34-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. 032265 and 032265) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SAG 4V (FLUCELVAX QUAD) for an unknown indication.    The patient's past medical history included COVID-19 on 28-Dec-2020. Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 2, lot numbers and dates were unknown.), Pfizer vaccine (Dose 1 and lot numbers and dates were unknown.). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.   On 30-Dec-2023, the patient received first dose of INFLUENZA VACCINE INACT SAG 4V (FLUCELVAX QUAD) (Intramuscular use) 1 dosage form. On 30-Dec-2023 at 10:31 AM, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 30-Dec-2023 at 10:32 AM, received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to .5 milliliter. On 30-Dec-2023, the patient experienced BRAIN FOG (Brain fog), INJECTION SITE PAIN (Muscle Pain at injection site), EXTRA DOSE ADMINISTERED (they accidentally administered 2 doses of Spikevax of 0.5 ml each to an adult patient) and ACCIDENTAL OVERDOSE (they accidentally administered 2 doses of Spikevax of 0.5 ml each to an adult patient). On 31-Dec-2023, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms included: generalized body aches, shivers, sweating). On 30-Dec-2023, BRAIN FOG (Brain fog) had resolved. On 31-Dec-2023, INFLUENZA LIKE ILLNESS (Flu like symptoms included: generalized body aches, shivers, sweating) and INJECTION SITE PAIN (Muscle Pain at injection site) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (they accidentally administered 2 doses of Spikevax of 0.5 ml each to an adult patient) and ACCIDENTAL OVERDOSE (they accidentally administered 2 doses of Spikevax of 0.5 ml each to an adult patient) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Patient did not have fever as measured with a thermometer..     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered BRAIN FOG (Brain fog), INFLUENZA LIKE ILLNESS (Flu like symptoms included: generalized body aches, shivers, sweating) and INJECTION SITE PAIN (Muscle Pain at injection site) to be related. No further causality assessments were provided for EXTRA DOSE ADMINISTERED (they accidentally administered 2 doses of Spikevax of 0.5 ml each to an adult patient) and ACCIDENTAL OVERDOSE (they accidentally administered 2 doses of Spikevax of 0.5 ml each to an adult patient).    It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  On 31-Dec-2023, at 03:00 P.M, the patient experienced flu like symptoms which included: generalized body aches, shivers and sweating. Patient did not have fever as measured with a thermometer.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2024: Significant follow up received, included : reporter details added, patient medical history updated, suspect product details (lot number) updated, co-suspect product details updated, added new events and narrative was updated accordingly.