Received Apr 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK378AB | IM / LL |
only the DTap-IPV component of the PENTACEL vaccine was administered to the patient, without its being reconstituted with the lyophilized Hib component, with no reported adverse event; Initial information received on 13-Mar-2026 regarding an unsolicited valid non-serious case received from healthcare professional. This case involves an infant patient who received only the DTap-IPV component of the Diphtheria, tetanus, acellular pertussis vaccine, poliomyelitis vaccine (inactivated), tetanus toxoid, diphtheria toxoid and haemophilus type B (HIB) vaccine (PENTACEL) vaccine was administered to the patient, without its being reconstituted with the lyophilized Hib component, with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. Concomitant medication(s) included rotavirus vaccine and pneumococcal vaccine conj 20v (CRM197). On 12-Mar-2026, the patient received 2nd dose, 0.5 ml of acellular pertussis vaccine, poliomyelitis vaccine (inactivated), tetanus toxoid, diphtheria toxoid and haemophilus type B (HIB) vaccine powder and suspension for suspension for injection (lot UK378ABand expiry 31-Mar-2027) (strength: unknown) without its being reconstituted with the lyophilized Hib component, with no reported adverse event (Single component of a two-component product administered) (latency same day) via intramuscular in left thigh route for Immunization. HCP stated that the patient was experiencing no adverse effects related to this dose. 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 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.
Rotavirus vaccine; Prevnar 20