Age: 5.0
Sex: M
Vaccine: FLUA4
Symptoms: Dyskinesia, Product administered to patient of inappropriate age, Syncope
Clinical narrative: Fainted; Seized up for a few seconds; Fluad Quadrivalent administered to 5 year old child; This spontaneous case was retrieved on 05-Dec-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2705906-1) reported by other healthcare professional and concerned a 5-year-old, male patient.   The patient's current condition and concomitant medications were not reported.  On 29-Oct-2023, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine inact sag 4v; route of administration: intramuscular, anatomical location: left arm (LA), dose and indication: not reported). The batch number reported was 370679. 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 Flucelvax Quadrivalent vaccine. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent Vaccine (explicitly coded as 'inappropriate age at vaccine administration').  On the same date, after receiving Fluad Quadrivalent vaccine, the patient had no issues, then the patient watched his mother get two vaccine and after that the patient fainted/seized up for a few seconds and then came too. The patient's sister was also in room crying hysterically prior to the fainting, which could have contributed. The patient was able to come to and 911 was called. An EMT did a patient assessment and determined vitals were normal and no hospitalization was required. The patient left pharmacy with mother.  On the same date, the patient recovered from the event of faint and 'movements involuntary'.  The reporter did not provide a causality assessment.    The event of faint was considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 5-year-old, male patient was vaccinated with Fluad Quadrivalent (explicitly coded as 'Inappropriate age at vaccine administration'). After the vaccination, patient watched his mother being vaccinated and fainted/seized up for a few seconds. Reportedly, the patient's sister was crying, which may have contributed to the development of events. Causal role of the suspect vaccine cannot be excluded, considering chronological plausibility, therefore syncope and dyskinesia are assessed as possibly related. Inappropriate age at vaccine administration is assessed as not related per company's conventions.; Sender's Comments: A 5-year-old, male patient was vaccinated with Fluad Quadrivalent (explicitly coded as 'Inappropriate age at vaccine administration'). After the vaccination, patient watched his mother being vaccinated and fainted/seized up for a few seconds. Reportedly, the patient's sister was crying, which may have contributed to the development of events. Causal role of the suspect vaccine cannot be excluded, considering chronological plausibility, therefore syncope and dyskinesia are assessed as possibly related. Inappropriate age at vaccine administration is assessed as not related per company's conventions.