Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK199AA | OT / LL |
pentacel was administered to a patient who is 5 years and 4 months old with no reported ae; Initial information received on 08-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a is 5 years and 4 months old female patient who was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) 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 Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) [Proquad] for Immunisation. On 07-May-2025, the patient received 0.5ml dose (once) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, Strength Standard, lot UK199AA and expiry date: 30-Apr-2026 via intramuscular route in the left thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (Latency same day). Reportedly, the patient was due for DTaP and IPV due to which Pentacel (Vero) was administered. No treatment was received by patient. 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.
PROQUAD