Received Feb 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | — |
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
supected vaccination failure/ extensive haemophilus influenzae serotype b disease in a fully vaccinated child; extensive haemophilus influenzae serotype b disease in a fully vaccinated child; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 10-month-old male patient who received Hib UNK (Hib vaccine) for hemophilus influenza infection. Literature Reference. Co-suspect products included Hib UNK (Hib vaccine) for hemophilus influenza infection and Hib UNK (Hib vaccine) for hemophilus influenza infection. Additional patient notes included no significant past medical history. On an unknown date, the patient received the 3rd dose of Hib vaccine, the 2nd dose of Hib vaccine and the 1st dose of Hib vaccine. On an unknown date, an unknown time after receiving Hib vaccine, Hib vaccine and Hib vaccine, the patient experienced vaccination failure (Verbatim: supected vaccination failure/ extensive haemophilus influenzae serotype b disease in a fully vaccinated child) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and haemophilus influenzae type b infection (Verbatim: extensive haemophilus influenzae serotype b disease in a fully vaccinated child) (serious criteria hospitalization and clinically significant/intervention required). The patient was treated with vancomycin, cefepime, ampicillin, ceftriaxone and amoxicillin. The outcome of the vaccination failure was not reported and the outcome of the haemophilus influenzae type b infection was resolving. The reporter considered the vaccination failure and haemophilus influenzae type b infection to be related to Hib vaccine, Hib vaccine and Hib vaccine. The company considered the vaccination failure and haemophilus influenzae type b infection to be unrelated to Hib vaccine, Hib vaccine and Hib vaccine. Additional Information: GSK receipt date: 16-FEB-2026 This case describes an unusual presentation of extensive invasive Hib disease in a fully immunized 10-month-old male with no significant past medical history. The patient presented with persistent fever, bilateral lower extremity swelling, and refusal to move all extremities. Magnetic resonance imaging (MRI) revealed widespread involvement of the bilateral hips and lower extremities, necessitating orthopedic surgical intervention. Blood and tissue cultures confirmed Hib on serotyping, while dissemination studies were negative for cardiac involvement or thrombosis. The patient was empirically started on vancomycin and cefepime, later narrowed to ampicillin based on bacterial speciation and susceptibility. Subsequent immunologic work-up was unremarkable and did not suggest an underlying immunodeficiency that would explain an inadequate vaccine response. A peripherally inserted central catheter (PICC) was placed, and patient was discharged on intravenous ceftriaxone. After PICC dislodgement, therapy was transitioned to high-dose oral amoxicillin to complete a four-week antibiotic course. Patient showed favorable recovery with follow-up in a combined orthopedic-infectious diseases clinic. This case report underscores the importance of maintaining a broad differential diagnosis. Invasive Hib infections can still occur in immunocompetent individuals despite adequate vaccination, highlighting the need to consider alternate sources and causative organisms that are usually prevented by vaccines. This case was considered to be suspected vaccination failure as the details regarding TTO was not reported.; Sender's Comments: A case of Vaccination failure and Haemophilus infection, unknown time after receiving 1st, 2nd and 3rd doses of Hib vaccine in a 10-month-old male patient. Causal relation is indeterminate. Case lacks further information on time to onset and vaccination schedule. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Comments: no significant past medical history
Test Name: Blood and tissue cultures; Result Unstructured Data: (Test Result:confirmed Hib on serotyping,Unit:unknown,Normal Low:,Normal High:); Test Name: Blood and tissue cultures; Result Unstructured Data: (Test Result:confirmed Hib on serotyping,Unit:unknown,Normal Low:,Normal High:); Comments: Magnetic resonance imaging (MRI) revealed widespread involvement of the bilateral hips and lower extremities, necessitating orthopedic surgical intervention. Dissemination studies were negative for cardiac involvement or thrombosis. Immunologic work-up was unremarkable and did not suggest an underlying immunodeficiency.