Reporte zur Charge UI906AAB

Symptomtext

presenting with a Sinus infection with thick green material coming out of nostril; Sinus infection with thick green material coming out of nostril; being positive for Haemophilus B Influenza with heavy growth of Beta-lactamases negative; being positive for Haemophilus B Influenza with heavy growth of Beta-lactamases negative; Initial information received on 20-Jan-2021 regarding an unsolicited valid serious case from other health professional. This case involves a 21-month-old male patient who was found positive for Haemophilus B influenza with heavy growth of beta-lactamases negative (haemophilus infection), sinus infection with thick green material coming out of nostril (sinusitis) (rhinorrhea), after receiving PENTACEL VACCINE and ACT-HIB. Medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was given to the patient. On 21-May-2019, the patient received a first dose of suspect HIB VACCINE (lot UI906AAB and expiration date not reported) via intramuscular route in unknown administration site for prophylactic vaccination. The patient received three doses of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ225AAA, UJ101AAA and UJ059AAA and expiration date not reported) via intramuscular route in unknown administration site for prophylactic vaccination on 08-Jul-2020, 19-Jul-2019 and 25-Sep-2019. On 04-Jan-2021, the patient was found positive for Haemophilus B influenza with heavy growth of beta-lactamases negative (haemophilus infection), 1 year 7 months 14 days following the administration of HIB VACCINE and 5 months 27 days following first dose, 1 year 3 months 10 days following the second dose and 1 year 5 months 16 days following the administration of third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a serious sinus infection with thick green material coming out of nostril (sinusitis) (rhinorrhea) (unknown latency) following the vaccination. These events were assessed as medically significant. This was also a case of vaccination failure (unknown latency) as the patient was positive for Haemophilus B influenza, despite being vaccinated with PENTACEL and ACT-HIB VACCINES. Relevant laboratory test results included: respiratory culture was performed on an unknown date and the patient was presented with sinus infection with thick green material coming out of nostril. On 04-Jan-2021: Haemophilus test: Positive and Pathogen resistance: Negative. The patient was prescribed Cefdinir. At the time of reporting, the outcome was unknown for all the events. The reporter also wanted to know if vaccine was resistant to their strain of the virus and would like a call back as soon as possible. Sender's Comments: This case involves a 21-month-old male patient who presented with Haemophilus infection, sinusitis and rhinorrhea, after vaccination with PENTACEL and ACT-HIB. The time to onset is compatible with the Haemophilus infection and unknown with the other reported events. It was also a case of vaccination failure. However, no information regarding patient's condition at time of vaccination, immune status and predisposition to respiratory infections is provided. Based upon the reported information, the role of an individual vaccine and a case of vaccination failure cannot be assessed.