Symptomtext
received an expired dose of FLUZONE; headache; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 29 years old female patient who experienced headache and received an expired dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meningococcal vaccine a/c/y/w conj (dip tox) (Menactra) for Prophylactic vaccination. On 24-Oct-2023, the patient received a dose of suspect influenza quadrival a-b multidose vaccine preserved [fluzone] suspension for injection (lot- U8096AA and expiration date- 30-Jun-2023) via intramuscular route in the left arm (dose, strength: not provided) for Immunisation (expired product administered) (latency- same day) On an unknown date in Oct- 2023 the patient developed headache (unknown latency) following the administration of Action taken- not applicable. It was not reported if the patient received a corrective treatment for the events (headache). At time of reporting, the outcome was Recovered / Resolved in 2023 for the event headache and was Unknown for the event received an expired dose of fluzone. 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.