Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 5 | UK224AC | OT / LL |
a 5 year and 1-day old patient was given PENTACEL with no reported adverse event; Initial information received on 11-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years and 1 day old female patient who received 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 prophylactic vaccination (Immunisation). On 11-Jun-2025, the patient received a dose of 0.5 ml (dose 5) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (lot UK224AC and expiry date 31-Jul-2026) (strength: standard and frequency: once) via intramuscular route in the left thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (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.
PROQUAD