Sex: F
Vaccine: DTAP, TDAP
Symptoms: Bordetella test positive, Pertussis, Vaccination failure
Clinical narrative: Suspected vaccination failure; Indeterminant B. pertussisc; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 13-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Concurrent medical conditions included pain ankle and cough.   On an unknown date, the patient received DTaP vaccine (unknown arm). On an unknown date, the patient received Tdap Vaccine (unknown arm). On an unknown date, an unknown time after receiving DTaP vaccine and Tdap Vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and pertussis (Verbatim: Indeterminant B. pertussisc) (serious criteria GSK medically significant). The outcome of the vaccination failure was unknown and the outcome of the pertussis was not reported.   The reporter considered the vaccination failure and pertussis to be related to DTaP vaccine and Tdap Vaccine.     The company considered the vaccination failure and pertussis to be related to DTaP vaccine and Tdap Vaccine.   Additional Information: GSK Receipt Date: 20-Nov-2023 This case corresponds to one female patient who developed Suspected vaccination failure and Indeterminant Bordetella pertussis. The author evaluated the prevalence of asymptomatic Bordetella carriage among acellular-vaccinated children and adolescents presenting for any reason to an emergency department (ED). The author conducted a cross-sectional, observational study nested within a pneumococcal carriage evaluation. A convenience sample of children 6-59 months or adolescents 11-17 years of age presenting to the ED of a tertiary-care hospital between December 1, 2017 and December 18, 2018 were enrolled. Children were not eligible if they were outside the indicated age groups, unable to participate due to severity of presenting disease, or were not a resident at enrollment. Pertussis vaccine history was confirmed by the Health Authority. Nasopharyngeal (NP) swabs were collected from each participant to test for the presence of Bordetella species. Participants were classified as up to date with pertussis vaccination if they met the following criteria: at least 3 doses of diphtheria toxoid, tetanus toxoid, and acellular pertussis vaccine (DTaP) by less than 2 years of age, at least 4 doses of DTaP by less than 6 years of age,  at least 4 doses of DTaP and 1 dose tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) or 5 doses of DTaP by less than 13 years of age, and at least 4 doses of DTaP and 1 dose of Tdap by less than 18 years of age. If no pertussis vaccinations were found in registry, the participant was classified as unvaccinated. Otherwise, the participant was classified as not up to date with pertussis vaccination. A total of 931 participants were enrolled and had a specimen available for testing; of these, 64 were excluded from the analysis due to PCR machine failure (23/931, 2.5percent) or negative Rnase P result (41/931, 4.4percent). Of the 867 included participants, 73percent (630/867) were aged 6-59 months and 27percent (237/867) were aged 11-17 years. The study population included participants presenting to an ED for any reason; additionally, reported pertussis incidence during the study timeframe was at its lowest level in 10 years. The author also reported that 13 years old female patient with laboratory finding- Indeterminant B. pertussis, Season of Enrollment- Spring, with Chief Complaint- Ankle pain and cough, Current cough-Yes, Pertussis-specific Symptoms- No, History of Cough Ill- ness in Past 6 Months- No, Antibiotic Use in Last 6 Months-No, Vaccinations Up to Date- Yes (5 dose of DTaP + Tdap),  Average CT Value for IS481- 39.21. This article is not available for regulatory reporting purpose due to copyright restriction.; Sender's Comments:  US-GSK-US2023GSK176928:Same Reporter Different Patient