Received May 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK346AA | IM / LL |
intentional by hcp,administration of first dose of the series at 4 months rather than 2 months of age with no reported adverse event; temperature excursion: negative disposition and product used, human error, no with no reported adverse event; Initial information regarding this unsolicited valid non-serious case downloaded from Regulatory Agency database without narrative (level 2A), was received on 22-Apr-2026 from Health Authorities via Health Care Professional (HCP). The following narrative is based on the information retrieved from all other accessible data. This case involves a 4-month-old female patient who had intentional administration by healthcare professional (HCP) of the first dose of Diphtheria/Tetanus/5, Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine-520 (Pentacel (Vero) series at 4 months rather than 2 months of age and temperature excursion with negative disposition and product used with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) and rotavirus vaccine live reassort 5v (RotaTeq). On 15-Apr-2026, the patient received a 0.5 mL of Diphtheria/Tetanus/5, Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection (batch: UK346AA, expiry: unknown) (strength: unknown) via intramuscular route in the left thigh for prophylactic vaccination (Immunisation). The healthcare professional (HCP) reported that the patient received a dose of Pentacel that was unsuitable for use due to an extended temperature excursion (Off label use, onset: 15-Apr-2026, latency: same day). The temperature excursion involved a technical failure of equipment with the product exposed to a maximum temperature of 15 degrees Celsius from 08-Apr-2026 to 21-Apr-2026 (13 days duration). Extended stability data did not cover the excursion, and the product was administered to the patient despite the unsuitability (Poor quality product administered, onset: 15-Apr-2026, latency: same day). The healthcare professional (HCP) stated that this was to have been the first dose in the series. The patient received the dose on 15-Apr-2026 intramuscularly into the left thigh. 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.
Comments: NONE
Prevnar 20; Rotateq