Age: 56.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Blood pressure measurement, Bronchitis bacterial, Essential hypertension, Oedema peripheral
Clinical narrative: High blood pressure / Essential hypertension; Bronchitis, mucopurulent recurrent; Ankle swelling; This spontaneous case was received on 07-Feb-2024 from other healthcare professional via agency (reference number: SEQW24-00546), reported by other healthcare professional and concerned a 57-year-old, female patient.  The patient's concurrent conditions included milk allergy, asthma, chest infection, chronic bronchitis, primary hypertension (blood pressure used to be 130/80, as reported), fasting blood glcose increased, vasomotor rhinitis, insect bite of shoulder and upper arm, non-venomous infected, anxiety, lower back pain, lyme disease, non-smoker, allergy to codeine phosphate and NSAIDs and weight loss. Historical condition included alcohol abuse. Past procedures included colonoscopy and tonsillectomy. The patient's concomitant medications included clonazepam for anxiety, Ventolin hfa (salbutamol sulfate) for asthma, Breo ellipta (fluticasone furoate, vilanterol trifenatate), montelukast sodium, multivitamin (multi for her), turmeric, glucosamine and vitamin C (ascorbic acid), for unknown indication. The patient's historical vaccines included three doses of Covid-19 vaccine (reported as Moderna), the first dose received on 30-Mar-2021 at 1:00 pm (route of administration: intramuscular (IM), anatomical location: arm, dose and indication: not reported, the batch number reported was 018BZ1A), the second dose received on 28-Apr-2021 (route of administration: IM, anatomical location: arm, dose and indication: not reported, the batch number reported was 045B21A) and the third dose received on 02-Dec-2021 (route of administration: IM, anatomical location: arm, dose and indication: not reported, the batch number reported was 0Y5J21A).  On 13-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 1, route of administration: IM, anatomical location: arm, indication: not reported) as influenza vaccine, as reported. The batch number reported was 348366.  On the same date, the patient was vaccinated with non-company, co-suspect Spikevax COVID-19 vaccine (elasomeran; route of administration: IM, anatomical location: arm, dose and indication: not reported). The batch number reported was A57165B.  On the same date, after receiving Flucelax Quadrivalent and non-company, co-suspect Covid-19 vaccine, the patient experienced blood pressure increased from the low side of normal to high (as reported, the blood pressure prior to vaccine was 138/62). Also, the patient felt that asthma which was well controlled prior to vaccine and had worsened after last vaccine and had been more poorly managed after vaccination and noticed some ankle swelling.  On 13-Dec-2022, the patient visited physician's room, and the physician made the assessments of essential hypertension, ankle edema and bronchitis, mucopurulent recurrent. The patient's treatment medications included Amlodipine at a dose of 5 mg, qd.  At the time of initial reporting, the patient had not recovered from the event of 'blood pressure high', and the outcome of the events 'ankle edema' and 'mucopurulent chronic bronchitis' was not reported.  The reporter did not provide a causality assessment.   The case is assessed as non-serious.  Company comment: A 57-year-old patient was vaccinated with Flucelvax Quadrivalent and with non-company, co-suspect Spikevax. On the same day following vaccination, the patient experienced essential hypertension, oedema peripheral and bronchitis bacterial. The patient's concurrent conditions included asthma, chest infection, chronic bronchitis, primary hypertension, blood glucose increased. Based on biological implausibility (for bronchitis bacterial) and multiple confounding factors, causality for the reported events of essential hypertension and bronchitis bacterial is assessed as not related. Causality is assessed as possible for oedema peripheral, due to suggestive chronology.; Sender's Comments: A 57-year-old patient was vaccinated with Flucelvax Quadrivalent and with non-company, co-suspect Spikevax. On the same day following vaccination, the patient experienced essential hypertension, oedema peripheral and bronchitis bacterial. The patient's concurrent conditions included asthma, chest infection, chronic bronchitis, primary hypertension, blood glucose increased. Based on biological implausibility (for bronchitis bacterial) and multiple confounding factors, causality for the reported events of essential hypertension and bronchitis bacterial is assessed as not related. Causality is assessed as possible for oedema peripheral, due to suggestive chronology.