Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 3 | UK363AA | OT / LL |
temperature excursion of act-hib; max/low temperature reached: 29.4 f (negative 1.444 c) duration: 15 minutes with no reported adverse event; Initial information received on 27-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 months old female patient who was administered with the suspect HIB (PRP/T) VACCINE [ACT-HIB] post excursion with maximum/lowest temperature reached: 29.4 Fahrenheit (negative 1.444 c) duration: 15 minutes 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 Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 27-Jan-2026, the patient received dose 3 (0.5 ml dosage) of suspect Hib (Prp/T) Vaccine , Powder and solvent for solution for injection, lot UK363AA, expiry date not reported, Frequency: Once, Strength: Standard via intramuscular route in the left vastus lateralis for Immunization, post excursion maximum/lowest temperature reached: 29.4 f (negative 1.444 c) duration: 15 minutes with no reported adverse event (product storage error). It was reported "human error was involved and product was administered. Previous excursion: None The extended stability data didn't cover the excursion". 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