Age: 26.0
Sex: F
Vaccine: FLUA4, FLUC3
Symptoms: Vaccination failure
Clinical narrative: Headache; Patient is Influenza A +; Patient is Influenza A + / Lack of efficacy; This spontaneous case was retrieved on 27-Dec-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2528428-1), reported by other healthcare professional and concerned a 26-year-old female patient.  The patient's concurrent conditions included attention deficit disorder (ADD), and kidney stone. The patient's historical procedure included cholecystectomy laparoscopic in May-2015, and lithotripsy on an unspecified date. The patient's concomitant medications included cetirizine for congestion, Flomax (tamsulosin hydrochloride), Mononessa (ethinylestradiol, norgestimate), Naprosyn (naproxen), and Vyvanse (lisdexamfetamine mesilate), all used for unreported indications. The patient had no known allergies. The patient's last menstrual period was on 06-Nov-2022. The patient denied alcohol use. The patient was a former user of electronic cigarette/vaping e-cigarette, quit more than 90 days prior to emergency department (ED) visit. The patient denied tobacco use.    It was reported that on 20-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration: injection (reported as 'SYR'); dose, anatomical location, and indication: not reported). The batch number reported was 942385. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On 07-Dec-2022, two months and 17 days after receiving Flucelvax Quadrivalent, the patient visited emergency department (ED) and tested positive for influenza A (explicitly coded as 'Vaccination failure').     On 10-Dec-2022, the patient visited ED again with complains of headache from that morning that was not relieved by Aleve (naproxen sodium) and Excedrin (acetylsalicylic acid, caffeine, paracetamol). Patient was Influenza A positive and was beginning to feel better of majority of flu symptoms. The patient had nausea without vomiting. The patient denied numbness/tingling/weakness/visual changes. Review of systems constitutional revealed: No fevers, no chills, no sweats; Eyes: no changes in vision, normal conjunctiva, clear sclera; Ears, nose, mouth, throat: no ear pain, no nasal congestion, no sore throat; Respiratory: no shortness of breath, no cough, no wheeze, lungs clear to auscultation (CTA), respirations non-labored; Cardiovascular: no chest pain, no palpitations, no edema, regular rate and rhythm, normal peripheral perfusion; Gastrointestinal: no abdominal pain, no nausea, no vomiting, no diarrhea, no constipation, soft, non-distended, no tenderness, no guarding; Genitourinary: no frequency, no urgency, no dysuria, no hematuria; Hematologic/Lymphatic: no bruising, no enlarged lymph nodes; Allergic/Immunologic: no hives; Endocrine: no cold intolerance, no heat intolerance, no polyuria, no polydipsia; Musculoskeletal: no arthralgia, no myalgia; Skin: no rash, no pruritus, warm, dry; Neurological: no headache, no focal weakness, no numbness, oriented x4, level of consciousness (LOC) appropriate for age, CNII-XII intact, motor strength equal and normal bilaterally, sensation equal and normal bilaterally, speech normal; Psychiatric: no anxiety, no depression, cooperative, appropriate for age affect, normal judgement, normal psychiatric thoughts. Physical Exam/Objective vitals and measurements last 24 hours: Vital signs: temperature: 37.1  degrees Celsius; heart rate: 84 beats per minute (bpm); respiratory rate: 18 breaths (br)/min; blood pressure (BP): 120/71 mmHg; oxygen saturation (SpO2): 99 % on room air; height: 172.7 cm; weight: 75.5 kg (ideal body weight: 63.88 kg); General: alert, no acute distress; Head: no trauma, normocephalic; Neck: trachea midline, no adenopathy, no tenderness; Chest wall: no deformity; Extremities: no deformity, no trauma. After assessment for influenza and headache, the patient was discharged with follow up plan and strict ED return instructions. All additional queries were answered. The patient was in stable condition. The patient was instructed to follow up with primary care provider within three to five days. The patient was given ketorolac 60 mg, intramuscularly, and promethazine 25 mg, orally.   At the time of initial reporting the patient was recovering from the event of 'Influenza A virus infection' as she was beginning to feel better of majority of flu symptoms. The patient had not recovered from the event of headache.   The reporter did not provide causality assessment.   The events of 'Influenza A virus infection' and 'Vaccination failure' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 26-year-old female patient was vaccinated with the suspect product Flucelvax Quadrivalent. Two months and 17 days after vaccination the patient visited emergency department (ED) and tested positive for influenza A (explicitly coded as 'Vaccination failure'). Three days later the patient experienced headache for which she visited ED. There were no significant findings detected following diagnostic workup. Based on plausible temporal relationship causality for influenza, vaccination failure and headache is assessed as possibly related.; Sender's Comments: A 26-year-old female patient was vaccinated with the suspect product Flucelvax Quadrivalent. Two months and 17 days after vaccination the patient visited emergency department (ED) and tested positive for influenza A (explicitly coded as 'Vaccination failure'). Three days later the patient experienced headache for which she visited ED. There were no significant findings detected following diagnostic workup. Based on plausible temporal relationship causality for influenza, vaccination failure and headache is assessed as possibly related.