Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Nasal polyps, Productive cough, Sinusitis, Tachycardia
Clinical narrative: got sick after having a flu shot in Nov-2024; developing flu like symptoms, and had mucus in her lungs; developing flu like symptoms, and had mucus in her lungs; adult patient is taking dupixent for sinusitis with no reported adverse event; tachycardia in which her heart rate went up to 160 at rest; vaginal yeast infections; immune system was affected by the medicine; Initial information received on 12-Sep-2024 was processed as non-case and upon follow-up received on 02-Jan-2025, the case became valid as an unsolicited valid non-serious case received from a patient.  This case involves a 58 years old female patient who had tachycardia in which her heart rate went up to 160 at rest, got sick after having a flu shot in nov-2024, developed flu like symptoms, and had mucus in her lungs, vaginal yeast infections while being treated with Dupilumab [Dupixent] delivered via Dupilumab singledose prefilled pen and Influenza vaccine  and adult patient was taking dupixent for sinusitis with nasal polyps with no reported adverse event directly linked to product use in unapproved indication.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included mepolizumab (nucala).  On 24-Jul-2024, the patient started taking Dupilumab solution for injection of strength 300mg/2ml at a dose of 600 mg once as loading dose and since then on unknown date 2024 the patient started 300 mg maintenance dose every other week (QOW) subcutaneously via Dupilumab singledose prefilled pen for Asthma, sinusitis with nasal polyps (product use in unapproved indication) (same day latency) (unknown batch number and expiry date).  In Nov-2024, the patient received a  dose of suspect Influenza vaccine produced by unknown manufacturer lot number not reported (unknown dose, route, strength for prophylactic vaccination).  In Nov-2024 the patient developed a non-serious event tachycardia in which her heart rate went up to 160 at rest (tachycardia) (approximately 5 months latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab and Influenza vaccine.  In Nov-2024 the patient developed a non-serious event got sick after having a flu shot in nov-2024 (illness) (approximately 5 months latency following the first dose intake (unknown batch number and expiry date) of Dupilumab and Influenza vaccine.  In Nov-2024 the patient developed a non-serious event developing flu like symptoms and had mucus in her lungs (influenza like illness) (productive cough) (approximately 5 months latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab and Influenza vaccine.  In 2024 the patient developed a non-serious vaginal yeast infections event (vulvovaginal mycotic infection) (unknown latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab and Influenza vaccine.  In 2024 the patient developed a non-serious event "immune system was affected by the medicine" (immune system disorder) (unknown latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab and Influenza vaccine.  Information regarding batch number and expiry date corresponding to one at the time of event occurrence was requested.  It was reported additional information was received on 02-Jan-2025 patient reported she had several health issues within the past 2 months, in which she got sick after having a flu shot in Nov-2024. she reports developing flu like symptoms, and had mucus in her lungs and her doctor of medicine (md) prescribed antibiotics. she was concerned that her immune system was affected by the medicine. she reported within that time frame she missed a dose and delayed another dose by one week due to being sick. she did not had a flare up in her symptoms due to the missed/delayed doses. she also had been getting more vaginal yeast infections (unknown onset). she also had tachycardia in which her heart rate went up to 160 at rest. this occurred a couple days after she was feeling better from her illness. md is not aware.   Relevant laboratory test results included: Heart rate - On an unknown date: [160 at rest]  Action taken with dupilumab: Drug withdrawn in 2024 for influenza like illness, productive cough, illness and unknown for tachycardia, vulvovaginal mycotic infection, immune system disorder. And with influenza vaccine: unknown for influenza like illness, productive cough, illness, tachycardia, vulvovaginal mycotic infection, immune system disorder.  Corrective treatment: Antibiotic (unspecified) for influenza like illness, productive cough, illness and not reported for tachycardia, vulvovaginal mycotic infection, immune system disorder.  At time of reporting, the outcome was Unknown for tachycardia, vulvovaginal mycotic infection, immune system disorder and Recovering / Resolving for influenza like illness, productive cough, illness.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.