Age: 73.0
Sex: F
Vaccine: FLU4, FLUA4
Symptoms: Blood culture, Full blood count, General physical health deterioration, Metabolic function test, Procalcitonin
Clinical narrative: Respiratory Distress; This spontaneous case was retrieved on 05-Dec-2023 from the Vaccine Adverse Event Reporting System (VAERS) (reference number: 2706537-1), reported by other healthcare professional and concerned a 73-year-old, female patient.  The patient's concurrent conditions included adult failure to thrive, allergy to alprazolam and meperidine, increased white blood cells (WBC) and chronic obstructive pulmonary disease (COPD) exacerbation per chest x-ray. The patient's concomitant medications included amlodipine, ferrous sulfate, Fosamax (alendronate sodium) all used for unspecified indication, and Z-pak (azithromycin) used for increased WBC and COPD exacerbation.  It was reported that on 29-Oct-2023, the patient was vaccinated with Afluria Quadrivalent, (influenza vaccine inact split 4v; dose: reported as '1'; route of administration: intramuscular; anatomical location: right arm; indication: not reported). The batch number reported was 371609. The reported batch number was identified by Seqirus to be linked to suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Afluria Quadrivalent. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent.  On 30-Oct-2023, one day after receiving the Fluad Quadrivalent, the patient experienced respiratory distress, and was sent to the emergency department (ED). Blood culture, complete blood count, basic metabolic panel, and procalcitonin were obtained, and the results were pending. No further information was provided.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The event of respiratory distress was considered to be medically significant by Physician within Seqirus's Regulatory Authority.  Company comment: A patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient experienced respiratory distress. Blood culture, complete blood count, basic metabolic panel, and procalcitonin were obtained, and the results were pending. No further information was provided. The patient's underlying chronic obstructive pulmonary disease exacerbation, highly confounds causality. Nevertheless, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the event respiratory distress, with the currently available information and chronological plausibility.; Sender's Comments: A patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient experienced respiratory distress. Blood culture, complete blood count, basic metabolic panel, and procalcitonin were obtained, and the results were pending. No further information was provided. The patient's underlying chronic obstructive pulmonary disease exacerbation, highly confounds causality. Nevertheless, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the event respiratory distress, with the currently available information and chronological plausibility.