Received Feb 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | U7931AB | OT / RL |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
dose of vQUADRACEL, was inadvertently administered to a patient under the age of 4 instead of Pentacel with no reported adverse event; Initial information received on 31-Jan-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves 3 months old female patient to whom inadvertently administered dose of diphtheria, tetanus, AC pertussis and IPV vaccine (Quadracel (VERO)) under the age of 4 instead of diphtheria, tetanus, ac pertussis, ipv and hib vaccine (pentacel (vero)) with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine live oral 1v (Rotarix). On 30-Jan-2025, the patient received a dose of 0.5 ml of suspect diphtheria, tetanus, AC pertussis and IPV vaccine (Quadracel (VERO)), Solution for injection (strength : standard) (frequency: once) (lot U7931AB and expiry date 09-Nov-2025) via intramuscular route in the right thigh for immunization and had inadvertently administered to a patient under the age of 4 instead of pentacel (wrong product administered) (Latency: same day). Action taken was not applicable. 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. Contact specialty is PediatricReporter can be contacted by Sanofi:YesPotential PTC:NoDescription:This situation is pre-assessed as a medication error/an inappropriate use due to use of the product in a patient under the age of 4. Physician reporting that a dose of vQUADRACEL, was inadvertently administered to a patient under the age of 4 instead of Pentacel. Caller is inquiring if the dose is valid or does it need to be repeated.Additional Description of eventAdverse events :Physician reporting that a dose of vQUADRACEL, was inadvertently administered to a patient under the age of 4 instead of Pentacel. Caller is inquiring if the dose is valid or does it need to be repeated.Pasteur AE ReportingRefunds/Credits will not be issued due to adverse events. Patient Informationo Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines needmonth for age. 3m Dosage Informationo Frequency = onceo Therapy Date: From = Date of immunization To = leave blanko Route = route & site INTRAMUSCULAR, RIGHT THIGH o Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.5 mLo Strength = standard except for Fluzone High Doseo Indications = Immunization or TB skin test IMMUNIZATION Event Informationo Treatmento Dose # if serieso List concomitant or no other vaccines ORAL ROTARIXo ER/Dr. visit and date 30Jan2025o Lot # U7931ABo Vaccine presentation/NDC #49281-564-88 Administering physiciano Full Name MDo Address Phone number Reporter relationship : HCPProduct used : Used
Rotarix