Reporte zur Charge UT76781MA

Symptomtext

pregnant female patient received another FLUZONE QIV NP in error with no reported adverse event; pregnant female patient received FLUZONE QIV NP with no reported adverse event; Initial information received on 21-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 20 years old female patient who is pregnant and received Influenza Quadrival A-B Vaccine [FLUZONE QIV] and another Influenza Quadrival A-B Vaccine in error with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The pregnant female patient received Influenza Quadrival A-B Vaccine [FLUZONE QIV] with no reported adverse event occurred at 10 weeks of pregnancy and another Influenza Quadrival A-B Vaccine in error with no reported adverse event occurred at 13 weeks of pregnancy and the patient was exposed to Influenza Quadrival A-B Vaccine at 10 weeks of pregnancy, during first pregnancy trimester for Influenza Quadrival A-B Vaccine. The date of last menstrual period was reported as 03-Aug-2022. The estimated due date is 10-May-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 25-Oct-2022, the patient received second dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection at a dose of 0.5 ml total (lot number: UT76781MA, expiry date: 30-Jun-2023, Strength: Standard) via intramuscular route in the left deltoid for immunisation. On 29-Sep-2022, she also received a dose 1 of the same vaccine (lot number: UT76781MA, Expiry date: 30-Jun-2023) (Drug Treatment Duration: Once) via intramuscular route in the left deltoid for immunisation On 29-Sep-2022, the pregnant female patient received Influenza Quadrival A-B Vaccine with no reported adverse event (exposure during pregnancy) (latency: same day) following the administration of Influenza Quadrival A-B Vaccine. On 25-Oct-2022, the pregnant female patient received another Influenza Quadrival A-B Vaccine in error with no reported adverse event (extra dose administered) latency: 27 days following the administration of Influenza Quadrival A-B Vaccine. Action taken: not applicable. Outcome: Unknown Additionally, at time of reporting, the pregnancy is still ongoing. 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.