Reporte zur Charge U7729AC

Symptomtext

went to get a Fluzone Quadrivalent prefilled syringe (no preservative) vaccine, however the HCP accidentally gave the Fluzone Quadrivalent MDV instead with no reported adverse event; Patient is in her third trimester of pregnancy; HCP accidentally gave the Fluzone Quadrivalent MDV with no reported adverse event; Initial information was received on 17-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional under Global Medical Information (GMI) Inquiry Number: 00862192 This case involves a 38 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in context of went to get a fluzone quadrivalent prefilled syringe (no preservative) vaccine, however the health care professional accidentally gave the fluzone quadrivalent multi dose vial (mdv) instead with no reported adverse event (wrong product administered) and patient was in her third trimester of pregnancy (exposure during pregnancy). Data regarding this pregnancy were received prospectively, i.e, before pregnancy outcome was known. Unknown gestation period, the gestation period at onset and gestation period at exposure data needs to be populated, if available. The date of last menstrual period was not reported. The estimated due date was 08-Jan-2022. The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided. The patient's previous pregnancy/ies were unknown. On 10-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: U7729AC and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was reported "The caller stated that she wants to enroll in the pregnancy registry for Fluzone. The patient then called her (obstetrician-gynaecologist) OB/GYN who said that it should be fine, however encouraged her to get on the pregnancy registry." It was a case of actual medication error due to wrong vaccine administered and vaccine exposure during pregnancy (latency: same day). Relevant prenatal testing after exposure were not known. Additionally, at time of reporting, the pregnancy was 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 by the regulatory authority. 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.