Age: 2.0
Sex: M
Vaccine: FLUC4
Symptoms: Bronchitis, Ear infection, Influenza, Product administered to patient of inappropriate age
Clinical narrative: Bronchitis; Ear infection; Diagnosed with the flu; Vaccine was administered to a 2-year-old patient; Flucelvax Quadrivalent administered in the leg; This is a spontaneous case, reported by other non-health professional to Agency [reference number: SEQ19-06849] and initially received on 20-Nov-2019 with additional information received on 22-Nov-2019 (being processed together), concerning a 2-year-old, male patient.  The patient had no relevant medical history. The patient's concomitant medications included Zithromax (azithromycin) for an unknown indication.   On 14-Oct-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: leg, batch number: 259811 and expiration date: not reported] (explicitly coded as Inappropriate age at vaccine administration' and Vaccine administered at inappropriate site') for influenza prophylaxis.  On an unreported date, an unknown amount of time after vaccination, the patient experienced ear infection and bronchitis, and was treated with unspecified antibiotics.  On 15-Nov-2019, the patient had first symptoms of flu, and on 19-Nov-2019, he was diagnosed with flu. The patient was treated with Tamiflu (oseltamivir phosphate).  At the time of initial reporting, the patient had not recovered from the event of flu, while the outcome of the events ear infection and bronchitis was not reported.  The event of 'flu' was assessed as serious (medically significant).   The reporter did not provide causality assessment.  Company Comment: The patient experienced influenza, bronchitis and ear infection after suspect product, Flucelvax QIV administration at inappropriate site and to patient of inappropriate age. Chronology is possible. It was only stated that flu was diagnosed, and no laboratory test was reported to confirm this diagnosis. Reportedly, the patient had no relevant medical history. Causality was confounded with concomitant medication, Zithromax (azithromycin). Product administered to patient of inappropriate age and product administered at inappropriate site are assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and all the other events is assessed as possibly related.; Sender's Comments: The patient experienced influenza, bronchitis and ear infection after suspect product, Flucelvax QIV administration at inappropriate site and to patient of inappropriate age. Chronology is possible. It was only stated that flu was diagnosed, and no laboratory test was reported to confirm this diagnosis. Reportedly, the patient had no relevant medical history. Causality was confounded with concomitant medication, Zithromax (azithromycin). Product administered to patient of inappropriate age and product administered at inappropriate site are assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and all the other events is assessed as possibly related.