Symptomtext
half of the vaccine leaked out of the injection site with no reported adverse event; Initial information received on 30-Nov-2023 regarding an unsolicited valid non-serious case received via pharmacist. This case involves a 48-year-old male patient and the reporter stated influenza quadrival A-B vaccine [Fluzone QIV] half of the vaccine leaked out of the injection site with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Nov-2023, the patient received a 0.5 ml dose of suspect influenza quadrival A-B vaccine, suspension for injection (strength: unknown) (lot: U8201EA, Expiry date: 20-Jun-2024) via intramuscular route in the right deltoid for immunization and half of the vaccine leaked out of the injection site with no reported adverse event (incorrect dose administered) (latency: same day) Reportedly, he administered the medication to the patient, there was no issues or leakage during the medication preparation, but when he injected it into the patient's deltoid, for some reason, perhaps it was because of the patient's body fat or body mass said the pharmacist, approximately half of the vaccine leaked out of the injection site. Pharmacist also asks if they should use the alternate deltoid as the injection site for re-vaccination This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.