Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Systemic inflammatory response syndrome
Clinical narrative: Systemic Inflammatory Response Syndrome to COVID-19 Vaccination, grade 3; This spontaneous case was reported by a physician and describes the occurrence of SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (Systemic Inflammatory Response Syndrome to COVID-19 Vaccination, grade 3) in a 36-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 immunization.     The patient's past medical history included Post-acute COVID-19 syndrome. Previously administered products included for COVID-19 immunization: BNT162b2 ((DOSE 1, SINGLE), when the patient was 33-year-old.) on 28-Apr-2021, BNT162b2 ((DOSE 2, SINGLE), when the patient was 33-year-old.) on 19-May-2021, BNT162b2 ((DOSE 3, SINGLE), when the patient was 33-year-old.) on 15-Dec-2021, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) ((DOSE 4, SINGLE) and when the patient was 34-year-old) on 21-Oct-2022. Past adverse reactions to the above products included No adverse effect with BNT162b2, BNT162b2, BNT162b2, Moderna COVID-19 Vaccine and Bivalent (Original and Omicron BA.4/BA.5). Concomitant products included Naltrexone hydrochloride (Naltrexone) from 22-Sep-2023 to an unknown date, Triamcinolone from 18-Aug-2022 to an unknown date, Famotidine from 01-Dec-2023 to an unknown date, Cetirizine hydrochloride (Cetirizine) from 12-Aug-2024 to an unknown date, Ivabradine hydrochloride (Ivabradine) from 01-Oct-2024 to an unknown date and Rizatriptan benzoate (Rizatriptan) from 01-Oct-2024 to an unknown date for an unknown indication.    On 10-Oct-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. On 11-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (Systemic Inflammatory Response Syndrome to COVID-19 Vaccination, grade 3) (seriousness criteria hospitalization, disability and medically significant). The patient was hospitalized from 11-Oct-2024 to 13-Oct-2024 due to SYSTEMIC INFLAMMATORY RESPONSE SYNDROME. The patient was treated with Vancomycin hydrochloride (Vancomycin) in October 2024 for Systemic inflammatory response syndrome, at an unspecified dose and frequency; Ceftriaxone sodium (Ceftriaxone) in October 2024 for Systemic inflammatory response syndrome, at an unspecified dose and frequency and Paracetamol (Acetaminophen) in October 2024 for Systemic inflammatory response syndrome, at an unspecified dose and frequency. On 13-Oct-2024, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (Systemic Inflammatory Response Syndrome to COVID-19 Vaccination, grade 3) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter considered SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (Systemic Inflammatory Response Syndrome to COVID-19 Vaccination, grade 3) to be related.    Previously on 24-May-2024 at 12:15, patient received first oral dose of nirmatrelvir, ritonavir; placebo (blinded therapy) orally for post-acute covid-19 syndrome and completed dosing on 18-Jun-2024 at 07:30, (daily dose: 100 mg, 300 mg bid).  On 11-Oct-2024 in the morning, the patient had symptoms of fever, chills, dizziness, and fatigue. The patient was sent to emergency department (ED), and admitted, patient was diagnosed with systemic inflammatory response syndrome (SIRS) (grade 3).  Therapeutic measures were taken as a result of systemic inflammatory response syndrome.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.