Sex: U
Vaccine: COVID19, FLUC3
Symptoms: Product use issue, Pyrexia, Respiratory tract congestion
Clinical narrative: Tested positive for COVID-19 and had a COVID-19 rebound symptoms after negative test; Sore throat; Cough; Congestion; Fever; Fatigue; Malaise; The patient received Flucelvax Quadrivalent and Spikevax on the same day in the same arm; This spontaneous case, initially received on 31-May-2024, was reported by a non health professional and concerns an patient of unknown age/gender.  The patient's historical vaccines included Pfizer/Biontech COVID-19 vaccine received on 05-Jan-2021, 26-Jan-2021 (batch numbers: EK9231, EL9261), Moderna COVID-19 vaccine received on 29-Nov-2021 and 21-Oct-2022 (batch numbers: 007CZ1A, 060F22A), all for unrepored indication.  Administration of company suspect drug(s): On 23-Oct-2023, the patient received Flucelvax Quadrivalent (influenza vaccine inact sag 4v) for Flu vaccine., Route of administration: Intramuscular, Anatomical Location: Left deltoid. Lot number: Not reported.   Non-company suspect drugs: On 23-Oct-2023, the patient received Spikevax (Elasomeran), Indication: COVID-19 prevention, Route of administration: Intramuscular, Anatomical Location: Left Arm. Lot number: Not reported.   Adverse reactions/events and outcomes: On 23-Oct-2023, the patient experienced The patient received Flucelvax Quadrivalent and Spikevax on the same day in the same arm (outcome: Not Reported, stop date: 21-Oct-2023).  On 12-Feb-2024, the patient experienced Tested positive for COVID-19 and had a COVID-19 rebound symptoms after negative test (Medically Significant, outcome: Recovered / Resolved, stop date: 26-Feb-2024). COVID-19 home antigen test was positive. The patient started with Paxlovid (nirmatrelvir, ritonavir) orally.  On an unspecified date in Feb-2024, the patient experienced Sore throat (outcome: Recovered / Resolved, stop date: 26-Feb-2024), Cough (outcome: Recovered / Resolved, stop date: 26-Feb-2024), Congestion (outcome: Recovered / Resolved, stop date: 26-Feb-2024), Fever (outcome: Recovered / Resolved, stop date: 26-Feb-2024), Fatigue (outcome: Recovered / Resolved, stop date: 26-Feb-2024), Malaise (outcome: Recovered / Resolved, stop date: 26-Feb-2024).  On 16-Feb-2024, the patient stopped with Paxlovid (nirmatrelvir, ritonavir).  Between 17-Feb-2024 and 19-Feb-2024, the patient tested negative multiple times.  On 21-Feb-2024, the patient symptoms returned. The patient experienced cough, malaise, and congestion. The patient tested positive and continued to experience rebound symptoms.  On 26-Feb-2024, the patient tested negative.  On 28-Feb-2024, the patient had a second negative test.  Non-drug treatment/Other action taken:  Flucelvax Quadrivalent action taken: Not Applicable Treatment medication: Paxlovid  Repoerter's assessment: The reporter did not provide a causality assessment. The reporter assessed the event of COVID-19 as serious.; Reporter's Comments: Causal role of the suspect vaccine is assessed as not related. There is no physiological connection by which vaccination with influenza vaccine could cause the event of COVID-19. For the rest of the events, causality is assessed based on implausible temporal relationship and they are likely to be symptoms of COVID-19.