Received May 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK434AA | IM / LL |
administration of only the Hib component for PENTACEL with no AE; Initial information received on 19-May-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (health care professional). This case involves a 1-year-old female patient who received only the Hib component for Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine-520 [Pentacel (Vero)] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant medication(s) included PCV20 (pneumococcal vaccine conj). On 18-May-2026, the patient received only the Hib component for a 0.5 mL single (1X) dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine-520 powder and suspension for suspension for injection (batch/lot number: UK434AA, expiration date: 30-Jun-2027) (strength: unknown) via intramuscular route in Left Vastus Lateralis for immunization [Immunisation] with no adverse event (single component of a two-component product administered) (Latency same day). Action taken: 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 medication 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.
Comments: NONE
Pneumococcal conjugate vaccine