Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK194AA | OT |
administration of PENTACEL via a gastrostomy tube (G tube) to a four-month-old patient with no AE; Initial information received on 17-Dec-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel] via a gastrostomy tube (g tube) with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 17-Dec-2025 at 15:13 hours, the patient received 0.5 ml (dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, lot UK194AA, expiry date: 31-Mar-2026, Strength: Standard, frequency:once not reported via gastroenteral use route in unknown administration site for Immunization with no adverse event (incorrect route of product administration) (latency: same day). It Was Reported "They Stated That They Needed To Make Sure Whether Readministering The Vaccine Is Correct, Since They Did Not Think That The Pentacel Dose Was Successfully Administered Due To It "Still Showing In The G Tube Rn [Registered Nurse] Stated That While The Pentacel Was Given Via A G Tube, It Could Not "Be Flushed Because Of The Mother Not Having The Proper Syringe That It Takes To Flush Out This G Tube Extension." They Noted That The Patient May Not Have Received Pentacel Since The Medication Was Still Showing In The G Tube. As A Result, They Intramuscularly Readministered Pentacel To The Patient, Specifically Via The Leg (Unspecified Whether Left Or Right)". 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.
Prevnar 20