Reporte zur Charge UT7096KA

Symptomtext

A 13 months old patient was given a FLUZONE QUADRIVALENT instead of Prevnar/ No AE; Initial information received on 12-May-2021 regarding an unsolicited valid non-serious case received from a other health care professional via physician (Reference number- 00598467). This case involves a 13 months old male patient who was given a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe lot number: UT7096KA, expiry date: 30-JUN-2021, frequency: once, strength: standard via intramuscular route in the right thigh on 12-May-2021for prophylactic vaccination instead of PREVNAR (Wrong product administered). The patient's past vaccinations included FLUZONE QUADRIVALENT from 12-OCT-2020 to 16-NOV-2020 first and second dose 0.5 ml via intramuscular route for prophylactic vaccination. The patient's medical history, medical treatments and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination. It was an actual medication error due to wrong vaccine administered (latency same day). Potential Product Technique Complain: No. Description: The FLUZONE QUADRIVALENT was given to a 13 months old patient but it was not given on the recommended due date. The patient got two doses in 2020 but was given the booster: the earliest date was 12/14/2021 and it was due on 11/16/2021 but it was on 12-May-2021. Reporter wants to make sure that there are no contraindications. The doctor also came on the phone and said she wants to call the mother back and tell her that the child will be ok. Her main question is that this has happened before and she can tell the mother that the child will be okay and that it is not a problem getting three flu shots in 1 season, there is no issue with the child getting a flu shot next season. The doctor said she was pretty sure it will not be a problem but she would like to hear from company too. The recommended date of next flu shot was 11/16/2021. Doctor said she had ordered Measles, Mumps, Rubella (MMR), varicella, Prevnar and Hepatitis A vaccines to be given today but instead of Prevnar, Fluzone Quadrivalent was given by mistake. Website says the earliest this child could get another flu vaccine is 14-Dec-2020. The Medical assistant had asked if based on that the child getting a flu shot today is ok. It was explained to caller that this has probably happened before but we do not have specifics and spoke for any side effects to look out for. Doctor was not satisfied with this answer, as she said this was not an overdose and the statement about no recommendations for getting multiple vaccines, she already knows, but since it has happened, can she tell the mother not to worry. At the time of report no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.