Symptomtext
Syncope; This spontaneous case was retrieved on 10-Nov-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2489803-1), reported by other healthcare professional and concerned a 12-year-old, male patient. The patient's medical history and concomitant medications were not reported. It was reported that on 24-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one', route of administration: intramuscular (IM), anatomical location: right arm (RA), indication: not reported). The batch number reported was 348362. 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 the same date, the patient was vaccinated with non-company co-suspect Gardasil 9 (hpv vaccine vlp rl1 9v (yeast); dose: reported as 'two', route of administration: intramuscular (IM), anatomical location: left arm (LA), indication: not reported). The batch number reported was U038662. On the same date, five and a half hours after receiving Flucelvax Quadrivalent and co-suspect Gardasil 9, the patient experienced syncope. On 25-Oct-2022, the patient had an ordered electrocardiogram (EKG), however, the results were not provided. At the time of initial reporting, the patient had not recovered from the event of syncope. The reporter did not provide a causality assessment. The event of syncope was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. Company comment: A 12-year-old, male patient was vaccinated with the Flucelvax Quadrivalent and non-company co-suspect Gardasil 9 vaccine. Five and a half hours after vaccination, the patient experienced syncope. The patient had an ordered electrocardiogram (EKG), however, the results were not provided. The patient's medical history and concomitant medications were not reported. Causality was confounded by concurrent administration of co-suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship.; Sender's Comments: A 12-year-old, male patient was vaccinated with the Flucelvax Quadrivalent and non-company co-suspect Gardasil 9 vaccine. Five and a half hours after vaccination, the patient experienced syncope. The patient had an ordered electrocardiogram (EKG), however, the results were not provided. The patient's medical history and concomitant medications were not reported. Causality was confounded by concurrent administration of co-suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship.